<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/NCT02995876</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-FixPro-02-2016</org_study_id>
    <nct_id>NCT02995876</nct_id>
  </id_info>
  <brief_title>The Clinical Performance of Inlay Zirconia Bridges</brief_title>
  <official_title>The Clinical Performance of Inlay Zirconia Bridges Using Three Different Designs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Damascus University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      When missing tooth structure or teeth are replaced, minimal biologic risk should be involved&#xD;
      to re-establish function and esthetics. The increased use of the adhesive technique and&#xD;
      preservation of dental tissues have greatly impacted conservative tooth preparation design.&#xD;
      The development use of zirconia technology and all-ceramic systems has opened the potential&#xD;
      for fabrication inlays zirconia bridges with durability and good aesthetics.&#xD;
&#xD;
      The purpose of this study is to clinically evaluate the placement of inlay bridge made of a&#xD;
      Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive&#xD;
      approach in the replacement of a single missing tooth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study evaluates the use of inlay bridge made of Zirconia and all ceramic systems with&#xD;
      three designs in the replacement process of one single tooth (i.e. a missing premolar or&#xD;
      molar.) The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal&#xD;
      surface from e-max press.&#xD;
&#xD;
      The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface&#xD;
      from e-max press and the internal surface coated with glaze layer to improve the adhesion.&#xD;
&#xD;
      The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface&#xD;
      from e-max press and the internal surface coated with a layer of e-max ceramic press to&#xD;
      improve the adhesion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in marginal fit</measure>
    <time_frame>Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application</time_frame>
    <description>To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Material Integrity</measure>
    <time_frame>Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application</time_frame>
    <description>To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Retention Status</measure>
    <time_frame>Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application</time_frame>
    <description>The resistance of a prosthesis to displacement will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Marginal Color Matching</measure>
    <time_frame>Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application</time_frame>
    <description>Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Sensitivity</measure>
    <time_frame>Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application</time_frame>
    <description>The presence of any spontaneous or stimulated pain will be assumed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patients' Satisfaction</measure>
    <time_frame>Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application</time_frame>
    <description>A questionnaire will be used to detect the level of satisfaction regarding function and shade</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Shade</measure>
    <time_frame>Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application</time_frame>
    <description>The shade is going to be determined using Vita(R) shade guide.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Dental Crowns</condition>
  <arm_group>
    <arm_group_label>Zirconia and E-max Press</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zirconia and E-max Press and Glaze</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with a glaze layer to improve adhesion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zirconia and E-max Press twice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with an E-max Press layer to improve adhesion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Glaze layer</intervention_name>
    <description>A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion</description>
    <arm_group_label>Zirconia and E-max Press and Glaze</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>E-max Press layer</intervention_name>
    <description>A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion</description>
    <arm_group_label>Zirconia and E-max Press twice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Good oral hygiene&#xD;
&#xD;
          2. Low susceptibility to caries&#xD;
&#xD;
          3. Parallel alignment of abutment teeth&#xD;
&#xD;
          4. Immobility of the abutment teeth&#xD;
&#xD;
          5. Minimum height of abutment teeth ≥ 5 mm (connector thickness)&#xD;
&#xD;
          6. Maximum mesio-distal extension of the inter-dental gap of 9 mm (width of premolar) or&#xD;
             12 mm (width of molar)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe para-functional habits.&#xD;
&#xD;
          -  Short clinical crowns (&lt;5 mm)&#xD;
&#xD;
          -  Extensive defects of the clinical crown,&#xD;
&#xD;
          -  Loosening of teeth because of factors related to the periodontal tissues.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mansour Abo Alkasab, DDS MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jihad Abo Nassar, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria</name>
      <address>
        <city>Damascus</city>
        <zip>DM20AM18</zip>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Coelho PG, Bonfante EA, Silva NR, Rekow ED, Thompson VP. Laboratory simulation of Y-TZP all-ceramic crown clinical failures. J Dent Res. 2009 Apr;88(4):382-6. doi: 10.1177/0022034509333968.</citation>
    <PMID>19407162</PMID>
  </reference>
  <reference>
    <citation>Cura C, Ozcan M, Isik G, Saracoglu A. Comparison of alternative adhesive cementation concepts for zirconia ceramic: glaze layer vs zirconia primer. J Adhes Dent. 2012 Feb;14(1):75-82. doi: 10.3290/j.jad.a21493.</citation>
    <PMID>21594233</PMID>
  </reference>
  <reference>
    <citation>Monaco C, Ferrari M, Caldari M, Baldissara P, Scotti R. Comparison of 2 bonding systems and survival of fiber-reinforced composite inlay fixed partial dentures. Int J Prosthodont. 2006 Nov-Dec;19(6):577-85.</citation>
    <PMID>17165297</PMID>
  </reference>
  <reference>
    <citation>Raigrodski AJ, Chiche GJ, Potiket N, Hochstedler JL, Mohamed SE, Billiot S, Mercante DE. The efficacy of posterior three-unit zirconium-oxide-based ceramic fixed partial dental prostheses: a prospective clinical pilot study. J Prosthet Dent. 2006 Oct;96(4):237-44. doi: 10.1016/j.prosdent.2006.08.010.</citation>
    <PMID>17052467</PMID>
  </reference>
  <reference>
    <citation>Sanli S, Comlekoglu MD, Comlekoglu E, Sonugelen M, Pamir T, Darvell BW. Influence of surface treatment on the resin-bonding of zirconia. Dent Mater. 2015 Jun;31(6):657-68. doi: 10.1016/j.dental.2015.03.004. Epub 2015 Apr 7.</citation>
    <PMID>25862408</PMID>
  </reference>
  <reference>
    <citation>Valentino TA, Borges GA, Borges LH, Platt JA, Correr-Sobrinho L. Influence of glazed zirconia on dual-cure luting agent bond strength. Oper Dent. 2012 Mar-Apr;37(2):181-7. doi: 10.2341/10-220-L. Epub 2011 Dec 14.</citation>
    <PMID>22166107</PMID>
  </reference>
  <reference>
    <citation>Chaar MS, Kern M. Five-year clinical outcome of posterior zirconia ceramic inlay-retained FDPs with a modified design. J Dent. 2015 Dec;43(12):1411-5. doi: 10.1016/j.jdent.2015.11.001. Epub 2015 Nov 10.</citation>
    <PMID>26561926</PMID>
  </reference>
  <results_reference>
    <citation>Monaco C, Cardelli P, Ozcan M. Inlay-retained zirconia fixed dental prostheses: modified designs for a completely adhesive approach. J Can Dent Assoc. 2011;77:b86.</citation>
    <PMID>21736862</PMID>
  </results_reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>September 9, 2018</last_update_submitted>
  <last_update_submitted_qc>September 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02995876
org study id: UDDS-FixPro-02-2016
nct id: NCT02995876
lead sponsor: 
has dmc: Yes
When missing tooth structure or teeth are replaced, minimal biologic risk should be involved
      to re-establish function and esthetics. The increased use of the adhesive technique and
      preservation of dental tissues have greatly impacted conservative tooth preparation design.
      The development use of zirconia technology and all-ceramic systems has opened the potential
      for fabrication inlays zirconia bridges with durability and good aesthetics.

      The purpose of this study is to clinically evaluate the placement of inlay bridge made of a
      Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive
      approach in the replacement of a single missing tooth.
This study evaluates the use of inlay bridge made of Zirconia and all ceramic systems with
      three designs in the replacement process of one single tooth (i.e. a missing premolar or
      molar.) The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal
      surface from e-max press.

      The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface
      from e-max press and the internal surface coated with glaze layer to improve the adhesion.

      The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface
      from e-max press and the internal surface coated with a layer of e-max ceramic press to
      improve the adhesion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in marginal fit
time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
description: To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.
measure: Change in Material Integrity
time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
description: To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.
measure: Change in the Retention Status
time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
description: The resistance of a prosthesis to displacement will be measured.
measure: Change in Marginal Color Matching
time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
description: Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays
measure: Change in Sensitivity
time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
description: The presence of any spontaneous or stimulated pain will be assumed.
measure: Change in Patients' Satisfaction
time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
description: A questionnaire will be used to detect the level of satisfaction regarding function and shade
measure: Change in Shade
time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
description: The shade is going to be determined using Vita(R) shade guide.
arm group label: Zirconia and E-max Press
arm group type: No Intervention
description: The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press.
arm group label: Zirconia and E-max Press and Glaze
arm group type: Experimental
description: The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with a glaze layer to improve adhesion.
arm group label: Zirconia and E-max Press twice
arm group type: Experimental
description: The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with an E-max Press layer to improve adhesion.
intervention type: Procedure
intervention name: Glaze layer
description: A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
arm group label: Zirconia and E-max Press and Glaze
intervention type: Procedure
intervention name: E-max Press layer
description: A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion
arm group label: Zirconia and E-max Press twice
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mansour Abo Alkasab, DDS MSc
role: Principal Investigator
affiliation: PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
last name: Jihad Abo Nassar, DDS MSc PhD
role: Study Director
affiliation: Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
facility: 
country: Syrian Arab Republic
citation: Coelho PG, Bonfante EA, Silva NR, Rekow ED, Thompson VP. Laboratory simulation of Y-TZP all-ceramic crown clinical failures. J Dent Res. 2009 Apr;88(4):382-6. doi: 10.1177/0022034509333968.
PMID: 19407162
citation: Cura C, Ozcan M, Isik G, Saracoglu A. Comparison of alternative adhesive cementation concepts for zirconia ceramic: glaze layer vs zirconia primer. J Adhes Dent. 2012 Feb;14(1):75-82. doi: 10.3290/j.jad.a21493.
PMID: 21594233
citation: Monaco C, Ferrari M, Caldari M, Baldissara P, Scotti R. Comparison of 2 bonding systems and survival of fiber-reinforced composite inlay fixed partial dentures. Int J Prosthodont. 2006 Nov-Dec;19(6):577-85.
PMID: 17165297
citation: Raigrodski AJ, Chiche GJ, Potiket N, Hochstedler JL, Mohamed SE, Billiot S, Mercante DE. The efficacy of posterior three-unit zirconium-oxide-based ceramic fixed partial dental prostheses: a prospective clinical pilot study. J Prosthet Dent. 2006 Oct;96(4):237-44. doi: 10.1016/j.prosdent.2006.08.010.
PMID: 17052467
citation: Sanli S, Comlekoglu MD, Comlekoglu E, Sonugelen M, Pamir T, Darvell BW. Influence of surface treatment on the resin-bonding of zirconia. Dent Mater. 2015 Jun;31(6):657-68. doi: 10.1016/j.dental.2015.03.004. Epub 2015 Apr 7.
PMID: 25862408
citation: Valentino TA, Borges GA, Borges LH, Platt JA, Correr-Sobrinho L. Influence of glazed zirconia on dual-cure luting agent bond strength. Oper Dent. 2012 Mar-Apr;37(2):181-7. doi: 10.2341/10-220-L. Epub 2011 Dec 14.
PMID: 22166107
citation: Chaar MS, Kern M. Five-year clinical outcome of posterior zirconia ceramic inlay-retained FDPs with a modified design. J Dent. 2015 Dec;43(12):1411-5. doi: 10.1016/j.jdent.2015.11.001. Epub 2015 Nov 10.
PMID: 26561926
citation: Monaco C, Cardelli P, Ozcan M. Inlay-retained zirconia fixed dental prostheses: modified designs for a completely adhesive approach. J Can Dent Assoc. 2011;77:b86.
PMID: 21736862
responsible party type: Sponsor
sharing ipd: No