<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/NCT01729858</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201601767-N</org_study_id>
    <secondary_id>K23DE018414</secondary_id>
    <nct_id>NCT01729858</nct_id>
  </id_info>
  <brief_title>Survival of Implant-Supported All-Ceramic Prostheses</brief_title>
  <official_title>Factors Influencing the Survival of Implant-Supported All-Ceramic Prostheses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ivoclar Vivadent AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dentsply Sirona Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to identify reasons that cause an all-ceramic bridge to&#xD;
      fracture which include the thickness of the bridge material, the type of bridge material and&#xD;
      the bite force of the person. This all-ceramic bridge will be compared to a metal-ceramic&#xD;
      bridge. The investigators are conducting this study so we can make bridges which can&#xD;
      withstand forces in the mouth which tend to break them.&#xD;
&#xD;
      The overall objective of this research is to analyze how properties of ceramic materials and&#xD;
      different forces in the mouth interact with each other to affect the longevity of these&#xD;
      bridges. These include fracture toughness, elastic modulus of ceramic layers and supporting&#xD;
      substrate, core thickness, connector height, wear, loading orientation, and maximum clenching&#xD;
      force.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The long-range goal of the proposed research is to formulate design survival statistics that&#xD;
      will aid the dental community in fabricating properly designed prostheses that can&#xD;
      predictably survive the oral environment.&#xD;
&#xD;
      Patients who qualify for this study will be randomized (as in chanced with the flip of a&#xD;
      coin) into two groups. The first group is a metal-ceramic group where patients will receive a&#xD;
      bridge with a metal substructure underneath. The second group is an all-ceramic group where&#xD;
      patients will receive a bridge which is made of hard ceramic material. All patients will&#xD;
      receive two dental implants which will bond to bone for a period of 4-6 months. An impression&#xD;
      or mold of the implants will then be made and a bridge will be fabricated based on the&#xD;
      randomization of the patient. Patients will be asked to return at 6 months and yearly&#xD;
      thereafter up to 5 years. During these recall appointments, photographs will be taken and&#xD;
      impressions of the bridge and other teeth will be made. This will allow us to measure the&#xD;
      amount of wear happening with the bridge and the other teeth. The investigators can also&#xD;
      examine the amount of bone around the implants as well as the integrity of the bridge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2008</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fracture</measure>
    <time_frame>A change from baseline to year 5</time_frame>
    <description>Any fracture or chipping of the prostheses reported by the participant or noted at recall periods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wear of prosthesis and enamel antagonist</measure>
    <time_frame>6 mos, 1 year, 2 year, 3 year, 4 year, 5 year</time_frame>
    <description>Wear of the prosthesis and the opposing enamel will be assessed at the recall appointments</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">106</enrollment>
  <condition>Partial Edentulism</condition>
  <condition>Disorder of Prostheses and Implants</condition>
  <condition>Dental Prosthesis Failure</condition>
  <arm_group>
    <arm_group_label>Metal-Ceramic</arm_group_label>
    <description>Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ceramic-Ceramic</arm_group_label>
    <description>Zirconia computer aided design and computer milled cores with press on veneers with different thicknesses, gingival embrasure diameters and connector heights.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ceramic-Ceramic</intervention_name>
    <description>Zirconia computer aided design and computer milled cores with press on veneers with different thicknesses, gingival embrasure diameters and connector heights.&#xD;
Fifty percent of the recruited subjects will be given a ceramic-ceramic bridge at baseline.</description>
    <arm_group_label>Ceramic-Ceramic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Metal-Ceramic</intervention_name>
    <description>Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights.&#xD;
Fifty percent of the recruited subjects will receive the metal-ceramic bridges at baseline.</description>
    <arm_group_label>Metal-Ceramic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients accessing a dental clinic for bridge placement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 21-75 years, and no contraindications to dental treatment.&#xD;
&#xD;
          -  Good overall dental health, no active caries, no periodontal disease, and periodontal&#xD;
             pocket depths not greater than 4 mm.&#xD;
&#xD;
          -  Missing at least three teeth in the posterior area of the mouth.&#xD;
&#xD;
          -  Natural teeth opposing the edentulous area and a full complement of teeth or restored&#xD;
             teeth in all other areas of the mouth&#xD;
&#xD;
          -  Adequate bone height and width at areas of proposed implant sites&#xD;
&#xD;
          -  Adequate interocclusal distance to accommodate prosthesis&#xD;
&#xD;
          -  Good oral hygiene and compliance with oral hygiene instructions as determined by the&#xD;
             amount of plaque present on tooth surfaces.&#xD;
&#xD;
          -  Compliance with appointments and willing to pay $2625 for a 3-unit implant supported&#xD;
             FDP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Non compliance Not enough teeth remaining Uncontrolled medical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josephine F Esquivel-Upshaw, DMD,MS,MS-CI</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth J Anusavice, PhD, DMD</last_name>
    <role>Study Director</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arthur E Clark, PhD, DMD</last_name>
    <role>Study Director</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Esquivel-Upshaw J, Mehler A, Clark A, Neal D, Gonzaga L, Anusavice K. Peri-implant complications for posterior endosteal implants. Clin Oral Implants Res. 2015 Dec;26(12):1390-6. doi: 10.1111/clr.12484. Epub 2014 Sep 27.</citation>
    <PMID>25263400</PMID>
  </reference>
  <reference>
    <citation>Esquivel-Upshaw JF, Mehler A, Clark AE, Neal D, Anusavice KJ. Fracture analysis of randomized implant-supported fixed dental prostheses. J Dent. 2014 Oct;42(10):1335-42. doi: 10.1016/j.jdent.2014.07.001. Epub 2014 Jul 9.</citation>
    <PMID>25016139</PMID>
  </reference>
  <results_reference>
    <citation>Esquivel-Upshaw JF, Clark AE, Shuster JJ, Anusavice KJ. Randomized clinical trial of implant-supported ceramic-ceramic and metal-ceramic fixed dental prostheses: preliminary results. J Prosthodont. 2014 Feb;23(2):73-82. doi: 10.1111/jopr.12066. Epub 2013 Jun 12.</citation>
    <PMID>23758092</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prosthesis Failure</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01729858
org study id: IRB201601767-N
secondary id: K23DE018414
nct id: NCT01729858
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this research study is to identify reasons that cause an all-ceramic bridge to
      fracture which include the thickness of the bridge material, the type of bridge material and
      the bite force of the person. This all-ceramic bridge will be compared to a metal-ceramic
      bridge. The investigators are conducting this study so we can make bridges which can
      withstand forces in the mouth which tend to break them.

      The overall objective of this research is to analyze how properties of ceramic materials and
      different forces in the mouth interact with each other to affect the longevity of these
      bridges. These include fracture toughness, elastic modulus of ceramic layers and supporting
      substrate, core thickness, connector height, wear, loading orientation, and maximum clenching
      force.
The long-range goal of the proposed research is to formulate design survival statistics that
      will aid the dental community in fabricating properly designed prostheses that can
      predictably survive the oral environment.

      Patients who qualify for this study will be randomized (as in chanced with the flip of a
      coin) into two groups. The first group is a metal-ceramic group where patients will receive a
      bridge with a metal substructure underneath. The second group is an all-ceramic group where
      patients will receive a bridge which is made of hard ceramic material. All patients will
      receive two dental implants which will bond to bone for a period of 4-6 months. An impression
      or mold of the implants will then be made and a bridge will be fabricated based on the
      randomization of the patient. Patients will be asked to return at 6 months and yearly
      thereafter up to 5 years. During these recall appointments, photographs will be taken and
      impressions of the bridge and other teeth will be made. This will allow us to measure the
      amount of wear happening with the bridge and the other teeth. The investigators can also
      examine the amount of bone around the implants as well as the integrity of the bridge.
observational model: Cohort
time perspective: Prospective
measure: Fracture
time frame: A change from baseline to year 5
description: Any fracture or chipping of the prostheses reported by the participant or noted at recall periods
measure: Wear of prosthesis and enamel antagonist
time frame: 6 mos, 1 year, 2 year, 3 year, 4 year, 5 year
description: Wear of the prosthesis and the opposing enamel will be assessed at the recall appointments
arm group label: Metal-Ceramic
description: Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights.
arm group label: Ceramic-Ceramic
description: Zirconia computer aided design and computer milled cores with press on veneers with different thicknesses, gingival embrasure diameters and connector heights.
intervention type: Device
intervention name: Ceramic-Ceramic
description: Zirconia computer aided design and computer milled cores with press on veneers with different thicknesses, gingival embrasure diameters and connector heights.
Fifty percent of the recruited subjects will be given a ceramic-ceramic bridge at baseline.
arm group label: Ceramic-Ceramic
intervention type: Device
intervention name: Metal-Ceramic
description: Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights.
Fifty percent of the recruited subjects will receive the metal-ceramic bridges at baseline.
arm group label: Metal-Ceramic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Josephine F Esquivel-Upshaw, DMD,MS,MS-CI
role: Principal Investigator
affiliation: University of Florida
last name: Kenneth J Anusavice, PhD, DMD
role: Study Director
affiliation: University of Florida
last name: Arthur E Clark, PhD, DMD
role: Study Director
affiliation: University of Florida
facility: 
country: United States
citation: Esquivel-Upshaw J, Mehler A, Clark A, Neal D, Gonzaga L, Anusavice K. Peri-implant complications for posterior endosteal implants. Clin Oral Implants Res. 2015 Dec;26(12):1390-6. doi: 10.1111/clr.12484. Epub 2014 Sep 27.
PMID: 25263400
citation: Esquivel-Upshaw JF, Mehler A, Clark AE, Neal D, Anusavice KJ. Fracture analysis of randomized implant-supported fixed dental prostheses. J Dent. 2014 Oct;42(10):1335-42. doi: 10.1016/j.jdent.2014.07.001. Epub 2014 Jul 9.
PMID: 25016139
citation: Esquivel-Upshaw JF, Clark AE, Shuster JJ, Anusavice KJ. Randomized clinical trial of implant-supported ceramic-ceramic and metal-ceramic fixed dental prostheses: preliminary results. J Prosthodont. 2014 Feb;23(2):73-82. doi: 10.1111/jopr.12066. Epub 2013 Jun 12.
PMID: 23758092
responsible party type: Sponsor
mesh term: Prosthesis Failure