<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03283709</url>
  </required_header>
  <id_info>
    <org_study_id>17-0511-F1V</org_study_id>
    <nct_id>NCT03283709</nct_id>
  </id_info>
  <brief_title>Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns</brief_title>
  <official_title>Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hiroko Nagaoka</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the use of an all-ceramic dental crown material&#xD;
      to restore the abutment teeth of partially-edentulous patients who need removable partial&#xD;
      dentures (RPD). The outcomes of the treatment group (all-ceramic crowns) will be compared to&#xD;
      a similarly-treated control group whose RPD abutment teeth are restored using conventional&#xD;
      metal and metal-ceramic crowns. Primary outcomes of interest include crown survival, abutment&#xD;
      tooth survival and RPD survival.The null hypothesis is that at the conclusion of the study&#xD;
      there will be no differences in outcomes between the two groups.&#xD;
&#xD;
      All dental treatment, including dental hygiene and periodontal care, fillings, crowns and RPD&#xD;
      fabrication will be provided by predoctoral dental students in the University of Kentucky&#xD;
      College of Dentistry student clinics. Students treating the subjects will be supervised by&#xD;
      licensed, technique-calibrated faculty specialists. Following the completion of dental&#xD;
      treatment, enrolled subjects will be clinically re-evaluated by investigators at 6 months,&#xD;
      and at annual intervals thereafter for 5 years following RPD delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate the use of highly esthetic, second and third generation&#xD;
      multi-layer zirconia crown materials to restore removable partial denture abutment teeth. All&#xD;
      performed treatment will be the standard of care and to the usual and customary standards&#xD;
      used in United states dental clinics for crown and RPD procedures. Treatment subjects will&#xD;
      have RPD abutment teeth restored with either Noritake Katana STML (anterior teeth) or HTML&#xD;
      (premolars and molars) zirconia crowns, and periodically evaluated for 60 months following&#xD;
      RPD delivery. Outcomes will be compared to a similarly treated control group restored with&#xD;
      metal, metal-ceramic, or a combination of metal and metal-ceramic crowns.&#xD;
&#xD;
      Following informed consent, subjects will be randomly assigned using an internet program&#xD;
      (https://www.randomizer.org/) to either a treatment (zirconia abutment tooth crown) or&#xD;
      control (metal or metal-ceramic abutment tooth crown) group. Using information from the oral&#xD;
      examination, articulated diagnostic casts will be evaluated , the RPD design confirmed, and&#xD;
      the need for a crown on one or more abutment teeth verified. Enrolled subjects will be given&#xD;
      oral hygiene instruction at the beginning of the study. They will also be instructed to brush&#xD;
      their teeth twice daily using an OTC fluoride dentifrice of their choice. They will also be&#xD;
      asked to use a 0.05% NaF oral rinse for 1 minute daily.&#xD;
&#xD;
      Abutment teeth must be in function with the opposing arch and vital at the beginning of the&#xD;
      study. Vitality will be be determined using a synthesis of history, percussion, palpation and&#xD;
      pulp testing. Pulp tests will be conducted using cold and an EPT, and the facial, lingual and&#xD;
      occlusal (incisal) surfaces of all abutment teeth will be tested for responsiveness. If&#xD;
      abutment tooth vitality is confirmed, teeth requiring surveyed crowns will be prepared and&#xD;
      restored using standardized clinical and laboratory guidelines.&#xD;
&#xD;
      Abutment teeth restored with metal and zirconia crowns will be prepared and restored using&#xD;
      the following clinical and laboratory guidelines. The margin will be a circumferential&#xD;
      chamfer prepared to a depth of 0.5 mm with a rounded internal line angle and a 90°&#xD;
      cavosurface exit angle. Margin height will be at or slightly coronal to the free gingival&#xD;
      margin where possible. Axial surfaces will be prepared with a total occlusal convergence of&#xD;
      &gt;6° but not to exceed 20°. Incisal and facial surfaces will be reduced 0.7-1.0 mm. Functional&#xD;
      surfaces will be reduced to 1.0 mm of opposing tooth clearance with the exception of under&#xD;
      rest seats, where opposing tooth clearance will be 2.0 mm. At completion, the prepared tooth&#xD;
      should have a height to base ratio of 0.4. If inadequate retention and resistance form is&#xD;
      identified following preparation of axial walls, supplementary grooves will be added, the&#xD;
      number and location of which are at the discretion of the investigator. Final impressions&#xD;
      will be made using PVS in a custom tray (Extrude) and poured in type V dental stone&#xD;
      (Jadestone). Following fabrication, the working cast will be articulated, tripoded, and the&#xD;
      die(s) sectioned, trimmed and scanned (3Shape D2000 laboratory scanner or equivalent). The&#xD;
      crown(s) will be waxed to full contour. Rest seats, undercuts and guide planes will then be&#xD;
      developed in wax. Once the waxup has been surveyed and finalized, it will be secured to the&#xD;
      scanning platform and a new scan performed with the waxup in place. The data file with the&#xD;
      die scan will be merged with the file that contains the waxup. The merged file will then be&#xD;
      transmitted to a designated production facility where the zirconia crown(s) will be milled.&#xD;
      Canines will be milled using Noritake Katana STML zirconia and premolars and molars will be&#xD;
      milled using Noritake Katana HTML zirconia. Once the crown(s) are returned and the margins,&#xD;
      contacts, occlusion and contours clinically verified, they will be luted using a&#xD;
      self-adhesive resin-based cement (RelyX Unicem 2).&#xD;
&#xD;
      Porcelain-fused-to-metal (PFM) crowns will be prepared and restored using a standard protocol&#xD;
      utilizing the following guidelines. Posterior crowns will have metal occlusal surfaces with&#xD;
      the porcelain-metal junction on the occlusal surface at half the distance between the central&#xD;
      groove and the buccal cusp tip. Mesial, distal and lingual surfaces will be in metal, and the&#xD;
      crown will have a disappearing metal margin on the facial surface. The facial preparation&#xD;
      from mesiofacial to distofacial line angles will be a heavy chamfer or modified shoulder&#xD;
      1.0-1.2 mm in depth with a rounded internal line angle and a 90° cavosurface exit angle.&#xD;
      Mesial, distal and lingual chamfer margins will be prepared to a horizontal depth of 0.5 mm.&#xD;
      Facial margin height will be at or slightly apical to the free gingival margin. Mesial,&#xD;
      distal and lingual margin height will be at or slightly coronal to the free gingival margin&#xD;
      if possible. Functional surfaces will be prepared with opposing tooth clearance of 1.5 mm&#xD;
      with the exception of under rest seats where opposing tooth clearance will be 2.0 mm.&#xD;
      Nonfunctional cusp reduction will be 1.0 mm. Final impressions will be made using PVS&#xD;
      (Extrude) in a custom tray and poured in type V dental stone (Jadestone). Following working&#xD;
      cast fabrication it will be articulated, tripoded, and the die(s) prepared for conventional&#xD;
      laboratory crown fabrication. Conventional (all-metal and PFM) surveyed crowns will be&#xD;
      fabricated using noble and high-noble casting alloys and PFM crowns will use feldspathic&#xD;
      porcelain as a veneering ceramic. Once the crown(s) are returned and the margins, contacts,&#xD;
      occlusion and contours clinically verified, they will be luted using a self-adhesive&#xD;
      resin-based cement (RelyX Unicem 2).&#xD;
&#xD;
      Qualifying RPD designs may be Kennedy class I-IV with up to two modification spaces, and will&#xD;
      be designed using a standardized protocol. Maxillary major connectors may consist of a&#xD;
      complete palatal plate, modified palatal plate, anterior-posterior palatal strap or palatal&#xD;
      strap. Mandibular major connectors will consist of either a lingual plate or a lingual bar.&#xD;
      Frameworks will be fabricated from nickel-chrome alloy (Ticonium), the denture bases acrylic&#xD;
      resin (Lucitone 199), and artificial teeth will be DENTSPLY Trubyte IPN Portrait. To meet the&#xD;
      definition of an RPD abutment tooth it must host a direct retainer consisting of an occlusal&#xD;
      or cingulum rest, a proximal plate and a retentive clasp. Reciprocation must be provided in&#xD;
      the form of a plate, reciprocating clasp or minor connector and rest. The plan for occlusion&#xD;
      will be based upon the number and distribution of remaining natural teeth. If an arch&#xD;
      opposing the RPD is edentulous and restored by a removable complete denture, then natural and&#xD;
      artificial teeth will be arranged in bilateral balance. If anterior guidance is present on&#xD;
      natural teeth in both arches it will be preserved so that artificial RPD teeth contact&#xD;
      opposing teeth in maximum intercuspation only.&#xD;
&#xD;
      Clinical assessments, procedures and annual examinations will be performed in the University&#xD;
      of Kentucky College of Dentistry second, third, and fourth floor student clinics. Clinical&#xD;
      procedures will be performed by third and fourth year dental students, and clinical&#xD;
      supervision for these procedures will be provided by licensed, calibrated investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated because PI left the institution.&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A prospective, randomized controlled trial comparing treatment outcomes for partial edentulism using two restorative materials. A convenience sample of study participants will be randomly assigned to either a treatment group or a control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Need to Replace Crown on RPD Abutment Tooth</measure>
    <time_frame>60 months</time_frame>
    <description>This is a collective measure reporting need to replace an abutment tooth crown for any reason. This includes repeated adhesive failure at crown interface due to inadequate retention/resistance form in the abutment tooth preparation, catastrophic fracture of monolithic or veneering crown ceramic necessitating crown replacement, primary or secondary caries involving crowned abutment tooth necessitating crown replacement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RPD Abutment Tooth Loss</measure>
    <time_frame>60 months</time_frame>
    <description>Loss of any RPD abutment tooth for any reason whether crowned or otherwise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RPD Failure</measure>
    <time_frame>60 months</time_frame>
    <description>Any technical or biologic complication resulting in loss of service of RPD. This includes loss of RPD as well as dissatisfaction and nonacceptance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tooth Loss</measure>
    <time_frame>60 months</time_frame>
    <description>Loss of any nonabutment tooth in either arch for any reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caries</measure>
    <time_frame>60 months</time_frame>
    <description>Dental caries involving any tooth in either arch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal Disease</measure>
    <time_frame>60 months</time_frame>
    <description>Change in clinical attachment level involving any tooth in either arch compared to baseline presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal Disease</measure>
    <time_frame>60 months</time_frame>
    <description>Increase or decrease in mobility involving any tooth in either arch compared to baseline presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal Disease</measure>
    <time_frame>60 months</time_frame>
    <description>Onset of fremitus involving any tooth in either arch relative to baseline presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal Disease</measure>
    <time_frame>60 months</time_frame>
    <description>Change in furcation classification involving any molar in either arch relative to baseline presentation..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal Disease</measure>
    <time_frame>60 months</time_frame>
    <description>Change in overall score for bleeding index compared to baseline presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal Disease</measure>
    <time_frame>60 months</time_frame>
    <description>Change in overall score for plaque index compared to baseline presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abutment Tooth Vitality</measure>
    <time_frame>60 months</time_frame>
    <description>Loss of vitality of any abutment tooth, crowned or otherwise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction and Quality of Life</measure>
    <time_frame>60 months</time_frame>
    <description>Change in patient satisfaction and quality of life, measured using the OHIP-14 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Crowns</condition>
  <condition>Denture</condition>
  <arm_group>
    <arm_group_label>Full-contour monolithic Zirconia crowns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional abutment crowns</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Full-contour monolithic zirconia abutment crowns</intervention_name>
    <description>Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
    <arm_group_label>Full-contour monolithic Zirconia crowns</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional abutment crowns</intervention_name>
    <description>Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
    <arm_group_label>Conventional abutment crowns</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Partially edentulous and treatment planned for an RPD&#xD;
&#xD;
          -  Requires at least 1 surveyed crown on an abutment tooth&#xD;
&#xD;
          -  Abutment teeth and RPD in function with opposing arch&#xD;
&#xD;
          -  Abutment teeth vital at time of study enrollment&#xD;
&#xD;
          -  English literacy, cognitively capable of understanding study and consent documents&#xD;
&#xD;
          -  Cognitively and functionally capable of performing prosthesis and oral self-care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any chronic or degenerative condition which impairs consent capability&#xD;
&#xD;
          -  Any cognitive or motor condition which impairs ability to follow instructions or&#xD;
             perform oral self-care&#xD;
&#xD;
          -  Healthy enough to tolerate planned dental procedures without premedication&#xD;
&#xD;
          -  Chronic infectious disease&#xD;
&#xD;
          -  COPD&#xD;
&#xD;
          -  Renal insufficiency&#xD;
&#xD;
          -  Autoimmune or chronic inflammatory disorders&#xD;
&#xD;
          -  Unstable asthma or diabetes&#xD;
&#xD;
          -  Unstable hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vaughan Hoefler, DDS, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky College of Dentistry</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536-0297</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Douglass CW, Watson AJ. Future needs for fixed and removable partial dentures in the United States. J Prosthet Dent. 2002 Jan;87(1):9-14. doi: 10.1067/mpr.2002.121204.</citation>
    <PMID>11807477</PMID>
  </reference>
  <reference>
    <citation>Campbell SD, Cooper L, Craddock H, Hyde TP, Nattress B, Pavitt SH, Seymour DW. Removable partial dentures: The clinical need for innovation. J Prosthet Dent. 2017 Sep;118(3):273-280. doi: 10.1016/j.prosdent.2017.01.008. Epub 2017 Mar 23.</citation>
    <PMID>28343666</PMID>
  </reference>
  <reference>
    <citation>Abt E, Carr AB, Worthington HV. Interventions for replacing missing teeth: partially absent dentition. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD003814. doi: 10.1002/14651858.CD003814.pub2.</citation>
    <PMID>22336794</PMID>
  </reference>
  <reference>
    <citation>Benso B, Kovalik AC, Jorge JH, Campanha NH. Failures in the rehabilitation treatment with removable partial dentures. Acta Odontol Scand. 2013 Nov;71(6):1351-5. doi: 10.3109/00016357.2013.777780. Epub 2013 Jul 9.</citation>
    <PMID>23834529</PMID>
  </reference>
  <reference>
    <citation>Ettinger RL, Goettsche ZS, Qian F. The Extent and Scope of Prosthodontic Practice in Iowa. J Prosthodont. 2019 Feb;28(2):113-121. doi: 10.1111/jopr.12588. Epub 2017 Mar 8.</citation>
    <PMID>28273692</PMID>
  </reference>
  <reference>
    <citation>Rehmann P, Orbach K, Ferger P, Wostmann B. Treatment outcomes with removable partial dentures: a retrospective analysis. Int J Prosthodont. 2013 Mar-Apr;26(2):147-50. doi: 10.11607/ijp.2959.</citation>
    <PMID>23476909</PMID>
  </reference>
  <reference>
    <citation>De Kok IJ, Cooper LF, Guckes AD, McGraw K, Wright RF, Barrero CJ, Bak SY, Stoner LO. Factors Influencing Removable Partial Denture Patient-Reported Outcomes of Quality of Life and Satisfaction: A Systematic Review. J Prosthodont. 2017 Jan;26(1):5-18. doi: 10.1111/jopr.12526. Epub 2016 Sep 6.</citation>
    <PMID>27598416</PMID>
  </reference>
  <reference>
    <citation>Murai S, Matsuda K, Ikebe K, Enoki K, Hatta K, Fujiwara K, Maeda Y. A field survey of the partially edentate elderly: Investigation of factors related to the usage rate of removable partial dentures. J Oral Rehabil. 2015 Nov;42(11):828-32. doi: 10.1111/joor.12318. Epub 2015 Jun 7.</citation>
    <PMID>26059645</PMID>
  </reference>
  <reference>
    <citation>Koyama S, Sasaki K, Yokoyama M, Sasaki T, Hanawa S. Evaluation of factors affecting the continuing use and patient satisfaction with Removable Partial Dentures over 5 years. J Prosthodont Res. 2010 Apr;54(2):97-101. doi: 10.1016/j.jpor.2009.11.007. Epub 2010 Jan 18.</citation>
    <PMID>20083450</PMID>
  </reference>
  <reference>
    <citation>Raigrodski AJ. Contemporary materials and technologies for all-ceramic fixed partial dentures: a review of the literature. J Prosthet Dent. 2004 Dec;92(6):557-62. doi: 10.1016/j.prosdent.2004.09.015.</citation>
    <PMID>15583562</PMID>
  </reference>
  <reference>
    <citation>Donovan TE. Factors essential for successful all-ceramic restorations. J Am Dent Assoc. 2008 Sep;139 Suppl:14S-18S. doi: 10.14219/jada.archive.2008.0360.</citation>
    <PMID>18768904</PMID>
  </reference>
  <reference>
    <citation>Kelly JR. Dental ceramics: what is this stuff anyway? J Am Dent Assoc. 2008 Sep;139 Suppl:4S-7S. doi: 10.14219/jada.archive.2008.0359. No abstract available.</citation>
    <PMID>18768902</PMID>
  </reference>
  <reference>
    <citation>Spear F, Holloway J. Which all-ceramic system is optimal for anterior esthetics? J Am Dent Assoc. 2008 Sep;139 Suppl:19S-24S. doi: 10.14219/jada.archive.2008.0358.</citation>
    <PMID>18768905</PMID>
  </reference>
  <reference>
    <citation>Sailer I, Makarov NA, Thoma DS, Zwahlen M, Pjetursson BE. All-ceramic or metal-ceramic tooth-supported fixed dental prostheses (FDPs)? A systematic review of the survival and complication rates. Part I: Single crowns (SCs). Dent Mater. 2015 Jun;31(6):603-23. doi: 10.1016/j.dental.2015.02.011. Epub 2015 Apr 2. Erratum In: Dent Mater. 2016 Dec;32(12 ):e389-e390.</citation>
    <PMID>25842099</PMID>
  </reference>
  <reference>
    <citation>Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014 Jan-Feb;27(1):33-43. doi: 10.11607/ijp.3647.</citation>
    <PMID>24392475</PMID>
  </reference>
  <reference>
    <citation>Le M, Papia E, Larsson C. The clinical success of tooth- and implant-supported zirconia-based fixed dental prostheses. A systematic review. J Oral Rehabil. 2015 Jun;42(6):467-80. doi: 10.1111/joor.12272. Epub 2015 Jan 10.</citation>
    <PMID>25580846</PMID>
  </reference>
  <reference>
    <citation>Ozkurt Z, Kazazoglu E. Clinical success of zirconia in dental applications. J Prosthodont. 2010 Jan;19(1):64-8. doi: 10.1111/j.1532-849X.2009.00513.x. Epub 2009 Sep 14.</citation>
    <PMID>19754642</PMID>
  </reference>
  <reference>
    <citation>Ozer F, Mante FK, Chiche G, Saleh N, Takeichi T, Blatz MB. A retrospective survey on long-term survival of posterior zirconia and porcelain-fused-to-metal crowns in private practice. Quintessence Int. 2014 Jan;45(1):31-8. doi: 10.3290/j.qi.a30768.</citation>
    <PMID>24392493</PMID>
  </reference>
  <reference>
    <citation>Burns DR, Unger JW. The construction of crowns for removable partial denture abutment teeth. Quintessence Int. 1994 Jul;25(7):471-5.</citation>
    <PMID>7991768</PMID>
  </reference>
  <reference>
    <citation>Kancyper S, Sierraalta M, Razzoog ME. All-ceramic surveyed crowns for removable partial denture abutments. J Prosthet Dent. 2000 Oct;84(4):400-2. doi: 10.1067/mpr.2000.110253.</citation>
    <PMID>11044845</PMID>
  </reference>
  <reference>
    <citation>Carracho JF, Razzoog ME. Removable partial denture abutments restored with all-ceramic surveyed crowns. Quintessence Int. 2006 Apr;37(4):283-8.</citation>
    <PMID>16594359</PMID>
  </reference>
  <reference>
    <citation>Yoon TH, Chang WG. The fabrication of a CAD/CAM ceramic crown to fit an existing partial removable dental prosthesis: a clinical report. J Prosthet Dent. 2012 Sep;108(3):143-6. doi: 10.1016/S0022-3913(12)60137-1.</citation>
    <PMID>22944309</PMID>
  </reference>
  <reference>
    <citation>Pihlaja J, Napankangas R, Kuoppala R, Raustia A. Veneered zirconia crowns as abutment teeth for partial removable dental prostheses: a clinical 4-year retrospective study. J Prosthet Dent. 2015 Nov;114(5):633-6. doi: 10.1016/j.prosdent.2015.05.008. Epub 2015 Sep 4.</citation>
    <PMID>26346419</PMID>
  </reference>
  <reference>
    <citation>Denry I, Kelly JR. Emerging ceramic-based materials for dentistry. J Dent Res. 2014 Dec;93(12):1235-42. doi: 10.1177/0022034514553627. Epub 2014 Oct 1.</citation>
    <PMID>25274751</PMID>
  </reference>
  <reference>
    <citation>Johansson C, Kmet G, Rivera J, Larsson C, Vult Von Steyern P. Fracture strength of monolithic all-ceramic crowns made of high translucent yttrium oxide-stabilized zirconium dioxide compared to porcelain-veneered crowns and lithium disilicate crowns. Acta Odontol Scand. 2014 Feb;72(2):145-53. doi: 10.3109/00016357.2013.822098. Epub 2013 Jul 18.</citation>
    <PMID>23865549</PMID>
  </reference>
  <reference>
    <citation>Stober T, Bermejo JL, Rammelsberg P, Schmitter M. Enamel wear caused by monolithic zirconia crowns after 6 months of clinical use. J Oral Rehabil. 2014 Apr;41(4):314-22. doi: 10.1111/joor.12139. Epub 2014 Jan 22.</citation>
    <PMID>24447258</PMID>
  </reference>
  <reference>
    <citation>Flinn BD, Raigrodski AJ, Mancl LA, Toivola R, Kuykendall T. Influence of aging on flexural strength of translucent zirconia for monolithic restorations. J Prosthet Dent. 2017 Feb;117(2):303-309. doi: 10.1016/j.prosdent.2016.06.010. Epub 2016 Sep 22.</citation>
    <PMID>27666494</PMID>
  </reference>
  <reference>
    <citation>Sulaiman TA, Abdulmajeed AA, Donovan TE, Ritter AV, Vallittu PK, Narhi TO, Lassila LV. Optical properties and light irradiance of monolithic zirconia at variable thicknesses. Dent Mater. 2015 Oct;31(10):1180-7. doi: 10.1016/j.dental.2015.06.016. Epub 2015 Jul 18.</citation>
    <PMID>26198027</PMID>
  </reference>
  <reference>
    <citation>Harada K, Raigrodski AJ, Chung KH, Flinn BD, Dogan S, Mancl LA. A comparative evaluation of the translucency of zirconias and lithium disilicate for monolithic restorations. J Prosthet Dent. 2016 Aug;116(2):257-63. doi: 10.1016/j.prosdent.2015.11.019. Epub 2016 Mar 17.</citation>
    <PMID>26994676</PMID>
  </reference>
  <reference>
    <citation>Sulaiman TA, Abdulmajeed AA, Donovan TE, Cooper LF, Walter R. Fracture rate of monolithic zirconia restorations up to 5 years: A dental laboratory survey. J Prosthet Dent. 2016 Sep;116(3):436-9. doi: 10.1016/j.prosdent.2016.01.033. Epub 2016 May 11. Erratum In: J Prosthet Dent. 2017 Jan;117(1):195.</citation>
    <PMID>27178771</PMID>
  </reference>
  <reference>
    <citation>Belli R, Petschelt A, Hofner B, Hajto J, Scherrer SS, Lohbauer U. Fracture Rates and Lifetime Estimations of CAD/CAM All-ceramic Restorations. J Dent Res. 2016 Jan;95(1):67-73. doi: 10.1177/0022034515608187. Epub 2015 Oct 1.</citation>
    <PMID>26428908</PMID>
  </reference>
  <reference>
    <citation>Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.</citation>
    <PMID>24980739</PMID>
  </reference>
  <reference>
    <citation>Ueda K, Guth JF, Erdelt K, Stimmelmayr M, Kappert H, Beuer F. Light transmittance by a multi-coloured zirconia material. Dent Mater J. 2015;34(3):310-4. doi: 10.4012/dmj.2014-238. Epub 2015 Apr 23.</citation>
    <PMID>25904173</PMID>
  </reference>
  <reference>
    <citation>Nordahl N, Vult von Steyern P, Larsson C. Fracture strength of ceramic monolithic crown systems of different thickness. J Oral Sci. 2015 Sep;57(3):255-61. doi: 10.2334/josnusd.57.255.</citation>
    <PMID>26369491</PMID>
  </reference>
  <reference>
    <citation>Stawarczyk B, Keul C, Eichberger M, Figge D, Edelhoff D, Lumkemann N. Three generations of zirconia: From veneered to monolithic. Part II. Quintessence Int. 2017;48(6):441-450. doi: 10.3290/j.qi.a38157.</citation>
    <PMID>28497132</PMID>
  </reference>
  <reference>
    <citation>Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.</citation>
    <PMID>8193981</PMID>
  </reference>
  <reference>
    <citation>Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.</citation>
    <PMID>9332805</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <results_first_submitted>March 2, 2020</results_first_submitted>
  <results_first_submitted_qc>March 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 13, 2020</results_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Hiroko Nagaoka</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03283709/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03283709/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Full-contour Monolithic Zirconia Crowns</title>
          <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
        </group>
        <group group_id="P2">
          <title>Conventional Abutment Crowns</title>
          <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>trial terminated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Trial was terminated early with only participant enrolled.</population>
      <group_list>
        <group group_id="B1">
          <title>Full-contour Monolithic Zirconia Crowns</title>
          <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
        </group>
        <group group_id="B2">
          <title>Conventional Abutment Crowns</title>
          <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Need to Replace Crown on RPD Abutment Tooth</title>
        <description>This is a collective measure reporting need to replace an abutment tooth crown for any reason. This includes repeated adhesive failure at crown interface due to inadequate retention/resistance form in the abutment tooth preparation, catastrophic fracture of monolithic or veneering crown ceramic necessitating crown replacement, primary or secondary caries involving crowned abutment tooth necessitating crown replacement</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Need to Replace Crown on RPD Abutment Tooth</title>
          <description>This is a collective measure reporting need to replace an abutment tooth crown for any reason. This includes repeated adhesive failure at crown interface due to inadequate retention/resistance form in the abutment tooth preparation, catastrophic fracture of monolithic or veneering crown ceramic necessitating crown replacement, primary or secondary caries involving crowned abutment tooth necessitating crown replacement</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RPD Abutment Tooth Loss</title>
        <description>Loss of any RPD abutment tooth for any reason whether crowned or otherwise.</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>RPD Abutment Tooth Loss</title>
          <description>Loss of any RPD abutment tooth for any reason whether crowned or otherwise.</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RPD Failure</title>
        <description>Any technical or biologic complication resulting in loss of service of RPD. This includes loss of RPD as well as dissatisfaction and nonacceptance</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>RPD Failure</title>
          <description>Any technical or biologic complication resulting in loss of service of RPD. This includes loss of RPD as well as dissatisfaction and nonacceptance</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tooth Loss</title>
        <description>Loss of any nonabutment tooth in either arch for any reason</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Tooth Loss</title>
          <description>Loss of any nonabutment tooth in either arch for any reason</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Caries</title>
        <description>Dental caries involving any tooth in either arch</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Caries</title>
          <description>Dental caries involving any tooth in either arch</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Periodontal Disease</title>
        <description>Change in clinical attachment level involving any tooth in either arch compared to baseline presentation.</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Disease</title>
          <description>Change in clinical attachment level involving any tooth in either arch compared to baseline presentation.</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Periodontal Disease</title>
        <description>Increase or decrease in mobility involving any tooth in either arch compared to baseline presentation.</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Disease</title>
          <description>Increase or decrease in mobility involving any tooth in either arch compared to baseline presentation.</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Periodontal Disease</title>
        <description>Onset of fremitus involving any tooth in either arch relative to baseline presentation.</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Disease</title>
          <description>Onset of fremitus involving any tooth in either arch relative to baseline presentation.</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Periodontal Disease</title>
        <description>Change in furcation classification involving any molar in either arch relative to baseline presentation..</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Disease</title>
          <description>Change in furcation classification involving any molar in either arch relative to baseline presentation..</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Periodontal Disease</title>
        <description>Change in overall score for bleeding index compared to baseline presentation.</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Disease</title>
          <description>Change in overall score for bleeding index compared to baseline presentation.</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Periodontal Disease</title>
        <description>Change in overall score for plaque index compared to baseline presentation.</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Disease</title>
          <description>Change in overall score for plaque index compared to baseline presentation.</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Abutment Tooth Vitality</title>
        <description>Loss of vitality of any abutment tooth, crowned or otherwise</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Abutment Tooth Vitality</title>
          <description>Loss of vitality of any abutment tooth, crowned or otherwise</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction and Quality of Life</title>
        <description>Change in patient satisfaction and quality of life, measured using the OHIP-14 questionnaire</description>
        <time_frame>60 months</time_frame>
        <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
        <group_list>
          <group group_id="O1">
            <title>Full-contour Monolithic Zirconia Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
          </group>
          <group group_id="O2">
            <title>Conventional Abutment Crowns</title>
            <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction and Quality of Life</title>
          <description>Change in patient satisfaction and quality of life, measured using the OHIP-14 questionnaire</description>
          <population>The single enrolled participant did not complete the intervention; thus, no data were generated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <desc>No participant completed the entire intervention due to trial termination (unrelated to adverse events). Thus, there are no adverse event or mortality data to report.</desc>
      <group_list>
        <group group_id="E1">
          <title>Full-contour Monolithic Zirconia Crowns</title>
          <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia&#xD;
Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia</description>
        </group>
        <group group_id="E2">
          <title>Conventional Abutment Crowns</title>
          <description>If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain&#xD;
Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Hiroko Nagaoka</name_or_title>
      <organization>University of Kentucky</organization>
      <phone>859-257-2101</phone>
      <email>h.nagaoka@uky.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03283709
org study id: 17-0511-F1V
nct id: NCT03283709
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to investigate the use of an all-ceramic dental crown material
      to restore the abutment teeth of partially-edentulous patients who need removable partial
      dentures (RPD). The outcomes of the treatment group (all-ceramic crowns) will be compared to
      a similarly-treated control group whose RPD abutment teeth are restored using conventional
      metal and metal-ceramic crowns. Primary outcomes of interest include crown survival, abutment
      tooth survival and RPD survival.The null hypothesis is that at the conclusion of the study
      there will be no differences in outcomes between the two groups.

      All dental treatment, including dental hygiene and periodontal care, fillings, crowns and RPD
      fabrication will be provided by predoctoral dental students in the University of Kentucky
      College of Dentistry student clinics. Students treating the subjects will be supervised by
      licensed, technique-calibrated faculty specialists. Following the completion of dental
      treatment, enrolled subjects will be clinically re-evaluated by investigators at 6 months,
      and at annual intervals thereafter for 5 years following RPD delivery.
This study will investigate the use of highly esthetic, second and third generation
      multi-layer zirconia crown materials to restore removable partial denture abutment teeth. All
      performed treatment will be the standard of care and to the usual and customary standards
      used in United states dental clinics for crown and RPD procedures. Treatment subjects will
      have RPD abutment teeth restored with either Noritake Katana STML (anterior teeth) or HTML
      (premolars and molars) zirconia crowns, and periodically evaluated for 60 months following
      RPD delivery. Outcomes will be compared to a similarly treated control group restored with
      metal, metal-ceramic, or a combination of metal and metal-ceramic crowns.

      Following informed consent, subjects will be randomly assigned using an internet program
      (https://www.randomizer.org/) to either a treatment (zirconia abutment tooth crown) or
      control (metal or metal-ceramic abutment tooth crown) group. Using information from the oral
      examination, articulated diagnostic casts will be evaluated , the RPD design confirmed, and
      the need for a crown on one or more abutment teeth verified. Enrolled subjects will be given
      oral hygiene instruction at the beginning of the study. They will also be instructed to brush
      their teeth twice daily using an OTC fluoride dentifrice of their choice. They will also be
      asked to use a 0.05% NaF oral rinse for 1 minute daily.

      Abutment teeth must be in function with the opposing arch and vital at the beginning of the
      study. Vitality will be be determined using a synthesis of history, percussion, palpation and
      pulp testing. Pulp tests will be conducted using cold and an EPT, and the facial, lingual and
      occlusal (incisal) surfaces of all abutment teeth will be tested for responsiveness. If
      abutment tooth vitality is confirmed, teeth requiring surveyed crowns will be prepared and
      restored using standardized clinical and laboratory guidelines.

      Abutment teeth restored with metal and zirconia crowns will be prepared and restored using
      the following clinical and laboratory guidelines. The margin will be a circumferential
      chamfer prepared to a depth of 0.5 mm with a rounded internal line angle and a 90°
      cavosurface exit angle. Margin height will be at or slightly coronal to the free gingival
      margin where possible. Axial surfaces will be prepared with a total occlusal convergence of
      >6° but not to exceed 20°. Incisal and facial surfaces will be reduced 0.7-1.0 mm. Functional
      surfaces will be reduced to 1.0 mm of opposing tooth clearance with the exception of under
      rest seats, where opposing tooth clearance will be 2.0 mm. At completion, the prepared tooth
      should have a height to base ratio of 0.4. If inadequate retention and resistance form is
      identified following preparation of axial walls, supplementary grooves will be added, the
      number and location of which are at the discretion of the investigator. Final impressions
      will be made using PVS in a custom tray (Extrude) and poured in type V dental stone
      (Jadestone). Following fabrication, the working cast will be articulated, tripoded, and the
      die(s) sectioned, trimmed and scanned (3Shape D2000 laboratory scanner or equivalent). The
      crown(s) will be waxed to full contour. Rest seats, undercuts and guide planes will then be
      developed in wax. Once the waxup has been surveyed and finalized, it will be secured to the
      scanning platform and a new scan performed with the waxup in place. The data file with the
      die scan will be merged with the file that contains the waxup. The merged file will then be
      transmitted to a designated production facility where the zirconia crown(s) will be milled.
      Canines will be milled using Noritake Katana STML zirconia and premolars and molars will be
      milled using Noritake Katana HTML zirconia. Once the crown(s) are returned and the margins,
      contacts, occlusion and contours clinically verified, they will be luted using a
      self-adhesive resin-based cement (RelyX Unicem 2).

      Porcelain-fused-to-metal (PFM) crowns will be prepared and restored using a standard protocol
      utilizing the following guidelines. Posterior crowns will have metal occlusal surfaces with
      the porcelain-metal junction on the occlusal surface at half the distance between the central
      groove and the buccal cusp tip. Mesial, distal and lingual surfaces will be in metal, and the
      crown will have a disappearing metal margin on the facial surface. The facial preparation
      from mesiofacial to distofacial line angles will be a heavy chamfer or modified shoulder
      1.0-1.2 mm in depth with a rounded internal line angle and a 90° cavosurface exit angle.
      Mesial, distal and lingual chamfer margins will be prepared to a horizontal depth of 0.5 mm.
      Facial margin height will be at or slightly apical to the free gingival margin. Mesial,
      distal and lingual margin height will be at or slightly coronal to the free gingival margin
      if possible. Functional surfaces will be prepared with opposing tooth clearance of 1.5 mm
      with the exception of under rest seats where opposing tooth clearance will be 2.0 mm.
      Nonfunctional cusp reduction will be 1.0 mm. Final impressions will be made using PVS
      (Extrude) in a custom tray and poured in type V dental stone (Jadestone). Following working
      cast fabrication it will be articulated, tripoded, and the die(s) prepared for conventional
      laboratory crown fabrication. Conventional (all-metal and PFM) surveyed crowns will be
      fabricated using noble and high-noble casting alloys and PFM crowns will use feldspathic
      porcelain as a veneering ceramic. Once the crown(s) are returned and the margins, contacts,
      occlusion and contours clinically verified, they will be luted using a self-adhesive
      resin-based cement (RelyX Unicem 2).

      Qualifying RPD designs may be Kennedy class I-IV with up to two modification spaces, and will
      be designed using a standardized protocol. Maxillary major connectors may consist of a
      complete palatal plate, modified palatal plate, anterior-posterior palatal strap or palatal
      strap. Mandibular major connectors will consist of either a lingual plate or a lingual bar.
      Frameworks will be fabricated from nickel-chrome alloy (Ticonium), the denture bases acrylic
      resin (Lucitone 199), and artificial teeth will be DENTSPLY Trubyte IPN Portrait. To meet the
      definition of an RPD abutment tooth it must host a direct retainer consisting of an occlusal
      or cingulum rest, a proximal plate and a retentive clasp. Reciprocation must be provided in
      the form of a plate, reciprocating clasp or minor connector and rest. The plan for occlusion
      will be based upon the number and distribution of remaining natural teeth. If an arch
      opposing the RPD is edentulous and restored by a removable complete denture, then natural and
      artificial teeth will be arranged in bilateral balance. If anterior guidance is present on
      natural teeth in both arches it will be preserved so that artificial RPD teeth contact
      opposing teeth in maximum intercuspation only.

      Clinical assessments, procedures and annual examinations will be performed in the University
      of Kentucky College of Dentistry second, third, and fourth floor student clinics. Clinical
      procedures will be performed by third and fourth year dental students, and clinical
      supervision for these procedures will be provided by licensed, calibrated investigators.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective, randomized controlled trial comparing treatment outcomes for partial edentulism using two restorative materials. A convenience sample of study participants will be randomly assigned to either a treatment group or a control group.
primary purpose: Treatment
masking: None (Open Label)
masking description: No masking
measure: Need to Replace Crown on RPD Abutment Tooth
time frame: 60 months
description: This is a collective measure reporting need to replace an abutment tooth crown for any reason. This includes repeated adhesive failure at crown interface due to inadequate retention/resistance form in the abutment tooth preparation, catastrophic fracture of monolithic or veneering crown ceramic necessitating crown replacement, primary or secondary caries involving crowned abutment tooth necessitating crown replacement
measure: RPD Abutment Tooth Loss
time frame: 60 months
description: Loss of any RPD abutment tooth for any reason whether crowned or otherwise.
measure: RPD Failure
time frame: 60 months
description: Any technical or biologic complication resulting in loss of service of RPD. This includes loss of RPD as well as dissatisfaction and nonacceptance
measure: Tooth Loss
time frame: 60 months
description: Loss of any nonabutment tooth in either arch for any reason
measure: Caries
time frame: 60 months
description: Dental caries involving any tooth in either arch
measure: Periodontal Disease
time frame: 60 months
description: Change in clinical attachment level involving any tooth in either arch compared to baseline presentation.
measure: Periodontal Disease
time frame: 60 months
description: Increase or decrease in mobility involving any tooth in either arch compared to baseline presentation.
measure: Periodontal Disease
time frame: 60 months
description: Onset of fremitus involving any tooth in either arch relative to baseline presentation.
measure: Periodontal Disease
time frame: 60 months
description: Change in furcation classification involving any molar in either arch relative to baseline presentation..
measure: Periodontal Disease
time frame: 60 months
description: Change in overall score for bleeding index compared to baseline presentation.
measure: Periodontal Disease
time frame: 60 months
description: Change in overall score for plaque index compared to baseline presentation.
measure: Abutment Tooth Vitality
time frame: 60 months
description: Loss of vitality of any abutment tooth, crowned or otherwise
measure: Patient Satisfaction and Quality of Life
time frame: 60 months
description: Change in patient satisfaction and quality of life, measured using the OHIP-14 questionnaire
arm group label: Full-contour monolithic Zirconia crowns
arm group type: Experimental
description: If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia
arm group label: Conventional abutment crowns
arm group type: Other
description: If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain
intervention type: Device
intervention name: Full-contour monolithic zirconia abutment crowns
description: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia
arm group label: Full-contour monolithic Zirconia crowns
intervention type: Device
intervention name: Conventional abutment crowns
description: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain
arm group label: Conventional abutment crowns
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vaughan Hoefler, DDS, MBA
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
citation: Douglass CW, Watson AJ. Future needs for fixed and removable partial dentures in the United States. J Prosthet Dent. 2002 Jan;87(1):9-14. doi: 10.1067/mpr.2002.121204.
PMID: 11807477
citation: Campbell SD, Cooper L, Craddock H, Hyde TP, Nattress B, Pavitt SH, Seymour DW. Removable partial dentures: The clinical need for innovation. J Prosthet Dent. 2017 Sep;118(3):273-280. doi: 10.1016/j.prosdent.2017.01.008. Epub 2017 Mar 23.
PMID: 28343666
citation: Abt E, Carr AB, Worthington HV. Interventions for replacing missing teeth: partially absent dentition. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD003814. doi: 10.1002/14651858.CD003814.pub2.
PMID: 22336794
citation: Benso B, Kovalik AC, Jorge JH, Campanha NH. Failures in the rehabilitation treatment with removable partial dentures. Acta Odontol Scand. 2013 Nov;71(6):1351-5. doi: 10.3109/00016357.2013.777780. Epub 2013 Jul 9.
PMID: 23834529
citation: Ettinger RL, Goettsche ZS, Qian F. The Extent and Scope of Prosthodontic Practice in Iowa. J Prosthodont. 2019 Feb;28(2):113-121. doi: 10.1111/jopr.12588. Epub 2017 Mar 8.
PMID: 28273692
citation: Rehmann P, Orbach K, Ferger P, Wostmann B. Treatment outcomes with removable partial dentures: a retrospective analysis. Int J Prosthodont. 2013 Mar-Apr;26(2):147-50. doi: 10.11607/ijp.2959.
PMID: 23476909
citation: De Kok IJ, Cooper LF, Guckes AD, McGraw K, Wright RF, Barrero CJ, Bak SY, Stoner LO. Factors Influencing Removable Partial Denture Patient-Reported Outcomes of Quality of Life and Satisfaction: A Systematic Review. J Prosthodont. 2017 Jan;26(1):5-18. doi: 10.1111/jopr.12526. Epub 2016 Sep 6.
PMID: 27598416
citation: Murai S, Matsuda K, Ikebe K, Enoki K, Hatta K, Fujiwara K, Maeda Y. A field survey of the partially edentate elderly: Investigation of factors related to the usage rate of removable partial dentures. J Oral Rehabil. 2015 Nov;42(11):828-32. doi: 10.1111/joor.12318. Epub 2015 Jun 7.
PMID: 26059645
citation: Koyama S, Sasaki K, Yokoyama M, Sasaki T, Hanawa S. Evaluation of factors affecting the continuing use and patient satisfaction with Removable Partial Dentures over 5 years. J Prosthodont Res. 2010 Apr;54(2):97-101. doi: 10.1016/j.jpor.2009.11.007. Epub 2010 Jan 18.
PMID: 20083450
citation: Raigrodski AJ. Contemporary materials and technologies for all-ceramic fixed partial dentures: a review of the literature. J Prosthet Dent. 2004 Dec;92(6):557-62. doi: 10.1016/j.prosdent.2004.09.015.
PMID: 15583562
citation: Donovan TE. Factors essential for successful all-ceramic restorations. J Am Dent Assoc. 2008 Sep;139 Suppl:14S-18S. doi: 10.14219/jada.archive.2008.0360.
PMID: 18768904
citation: Kelly JR. Dental ceramics: what is this stuff anyway? J Am Dent Assoc. 2008 Sep;139 Suppl:4S-7S. doi: 10.14219/jada.archive.2008.0359. No abstract available.
PMID: 18768902
citation: Spear F, Holloway J. Which all-ceramic system is optimal for anterior esthetics? J Am Dent Assoc. 2008 Sep;139 Suppl:19S-24S. doi: 10.14219/jada.archive.2008.0358.
PMID: 18768905
citation: Sailer I, Makarov NA, Thoma DS, Zwahlen M, Pjetursson BE. All-ceramic or metal-ceramic tooth-supported fixed dental prostheses (FDPs)? A systematic review of the survival and complication rates. Part I: Single crowns (SCs). Dent Mater. 2015 Jun;31(6):603-23. doi: 10.1016/j.dental.2015.02.011. Epub 2015 Apr 2. Erratum In: Dent Mater. 2016 Dec;32(12 ):e389-e390.
PMID: 25842099
citation: Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014 Jan-Feb;27(1):33-43. doi: 10.11607/ijp.3647.
PMID: 24392475
citation: Le M, Papia E, Larsson C. The clinical success of tooth- and implant-supported zirconia-based fixed dental prostheses. A systematic review. J Oral Rehabil. 2015 Jun;42(6):467-80. doi: 10.1111/joor.12272. Epub 2015 Jan 10.
PMID: 25580846
citation: Ozkurt Z, Kazazoglu E. Clinical success of zirconia in dental applications. J Prosthodont. 2010 Jan;19(1):64-8. doi: 10.1111/j.1532-849X.2009.00513.x. Epub 2009 Sep 14.
PMID: 19754642
citation: Ozer F, Mante FK, Chiche G, Saleh N, Takeichi T, Blatz MB. A retrospective survey on long-term survival of posterior zirconia and porcelain-fused-to-metal crowns in private practice. Quintessence Int. 2014 Jan;45(1):31-8. doi: 10.3290/j.qi.a30768.
PMID: 24392493
citation: Burns DR, Unger JW. The construction of crowns for removable partial denture abutment teeth. Quintessence Int. 1994 Jul;25(7):471-5.
PMID: 7991768
citation: Kancyper S, Sierraalta M, Razzoog ME. All-ceramic surveyed crowns for removable partial denture abutments. J Prosthet Dent. 2000 Oct;84(4):400-2. doi: 10.1067/mpr.2000.110253.
PMID: 11044845
citation: Carracho JF, Razzoog ME. Removable partial denture abutments restored with all-ceramic surveyed crowns. Quintessence Int. 2006 Apr;37(4):283-8.
PMID: 16594359
citation: Yoon TH, Chang WG. The fabrication of a CAD/CAM ceramic crown to fit an existing partial removable dental prosthesis: a clinical report. J Prosthet Dent. 2012 Sep;108(3):143-6. doi: 10.1016/S0022-3913(12)60137-1.
PMID: 22944309
citation: Pihlaja J, Napankangas R, Kuoppala R, Raustia A. Veneered zirconia crowns as abutment teeth for partial removable dental prostheses: a clinical 4-year retrospective study. J Prosthet Dent. 2015 Nov;114(5):633-6. doi: 10.1016/j.prosdent.2015.05.008. Epub 2015 Sep 4.
PMID: 26346419
citation: Denry I, Kelly JR. Emerging ceramic-based materials for dentistry. J Dent Res. 2014 Dec;93(12):1235-42. doi: 10.1177/0022034514553627. Epub 2014 Oct 1.
PMID: 25274751
citation: Johansson C, Kmet G, Rivera J, Larsson C, Vult Von Steyern P. Fracture strength of monolithic all-ceramic crowns made of high translucent yttrium oxide-stabilized zirconium dioxide compared to porcelain-veneered crowns and lithium disilicate crowns. Acta Odontol Scand. 2014 Feb;72(2):145-53. doi: 10.3109/00016357.2013.822098. Epub 2013 Jul 18.
PMID: 23865549
citation: Stober T, Bermejo JL, Rammelsberg P, Schmitter M. Enamel wear caused by monolithic zirconia crowns after 6 months of clinical use. J Oral Rehabil. 2014 Apr;41(4):314-22. doi: 10.1111/joor.12139. Epub 2014 Jan 22.
PMID: 24447258
citation: Flinn BD, Raigrodski AJ, Mancl LA, Toivola R, Kuykendall T. Influence of aging on flexural strength of translucent zirconia for monolithic restorations. J Prosthet Dent. 2017 Feb;117(2):303-309. doi: 10.1016/j.prosdent.2016.06.010. Epub 2016 Sep 22.
PMID: 27666494
citation: Sulaiman TA, Abdulmajeed AA, Donovan TE, Ritter AV, Vallittu PK, Narhi TO, Lassila LV. Optical properties and light irradiance of monolithic zirconia at variable thicknesses. Dent Mater. 2015 Oct;31(10):1180-7. doi: 10.1016/j.dental.2015.06.016. Epub 2015 Jul 18.
PMID: 26198027
citation: Harada K, Raigrodski AJ, Chung KH, Flinn BD, Dogan S, Mancl LA. A comparative evaluation of the translucency of zirconias and lithium disilicate for monolithic restorations. J Prosthet Dent. 2016 Aug;116(2):257-63. doi: 10.1016/j.prosdent.2015.11.019. Epub 2016 Mar 17.
PMID: 26994676
citation: Sulaiman TA, Abdulmajeed AA, Donovan TE, Cooper LF, Walter R. Fracture rate of monolithic zirconia restorations up to 5 years: A dental laboratory survey. J Prosthet Dent. 2016 Sep;116(3):436-9. doi: 10.1016/j.prosdent.2016.01.033. Epub 2016 May 11. Erratum In: J Prosthet Dent. 2017 Jan;117(1):195.
PMID: 27178771
citation: Belli R, Petschelt A, Hofner B, Hajto J, Scherrer SS, Lohbauer U. Fracture Rates and Lifetime Estimations of CAD/CAM All-ceramic Restorations. J Dent Res. 2016 Jan;95(1):67-73. doi: 10.1177/0022034515608187. Epub 2015 Oct 1.
PMID: 26428908
citation: Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.
PMID: 24980739
citation: Ueda K, Guth JF, Erdelt K, Stimmelmayr M, Kappert H, Beuer F. Light transmittance by a multi-coloured zirconia material. Dent Mater J. 2015;34(3):310-4. doi: 10.4012/dmj.2014-238. Epub 2015 Apr 23.
PMID: 25904173
citation: Nordahl N, Vult von Steyern P, Larsson C. Fracture strength of ceramic monolithic crown systems of different thickness. J Oral Sci. 2015 Sep;57(3):255-61. doi: 10.2334/josnusd.57.255.
PMID: 26369491
citation: Stawarczyk B, Keul C, Eichberger M, Figge D, Edelhoff D, Lumkemann N. Three generations of zirconia: From veneered to monolithic. Part II. Quintessence Int. 2017;48(6):441-450. doi: 10.3290/j.qi.a38157.
PMID: 28497132
citation: Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
PMID: 8193981
citation: Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
PMID: 9332805
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Hiroko Nagaoka
investigator title: Assistant Professor
sharing ipd: No
ipd description: There is not a plan to make IPD available
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