<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/NCT04474093</url>
  </required_header>
  <id_info>
    <org_study_id>KA-16029</org_study_id>
    <secondary_id>THD-2016-11741</secondary_id>
    <nct_id>NCT04474093</nct_id>
  </id_info>
  <brief_title>Monolithic CAD/CAM Single Tooth Ceramic Crowns</brief_title>
  <official_title>Monolithic CAD/CAM Single Tooth Crowns Made From Different Ceramics: One Year Preliminary Results of a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      With the development of Computer Aided Design and Computer Aided manufacturing (CAD / CAM)&#xD;
      systems, all ceramic restorations have been used with high success rates during the past 30&#xD;
      years in order to eliminate the disadvantages of metal ceramic restorations. Based on these&#xD;
      developments, in every passing days new ceramic materials has been added to dental market.&#xD;
      The aim of the present study was evaluating clinical results of single-tooth ceramic crowns&#xD;
      in the posterior region produced from three different monolithic ceramic materials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate and success (changes over time)</measure>
    <time_frame>1 year (Baseline to 12 months)</time_frame>
    <description>12 crowns were made from each group of three different ceramics: ZRGC, LDGC and RIGC. Thereafter, the restorations was evaluated in terms of any failure or loss of the restoration at any follow-up (6th and 12th months) periods. The results were obtained proportionally in percent (%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prosthetic evaluation changes</measure>
    <time_frame>1 year (Baseline to 12 months)</time_frame>
    <description>As recorded at the baseline (0), each restoration was assessed according to the modified the United States Public Health Service (USPHS) Ryge Criteria for prosthetic evaluation by a calibrated prosthodontics.USPHS criteria is based on the following ratings: Color match (Alpha,Bravo, Charlie), cavosurface marginal discoloration (Alpha,Bravo, Charlie), secondary caries (Alpha,Bravo), anatomic contour (Alpha,Bravo, Charlie), marginal integrity (Alpha,Bravo, Charlie), surface texture (Alpha,Bravo, Charlie) and gross fracture (Alpha,Bravo, Charlie).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal evaluation changes</measure>
    <time_frame>1 year (Baseline to 12 months)</time_frame>
    <description>Probing depth(PD): Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket (mm).&#xD;
Clinical attachment level(CAL): The loss of CAL were measured and calculated by measuring recession and subtracting the periodontal probing depth (mm).&#xD;
Gingival bleeding time index(GBTI): The probe were swiped at apical portion of the gingival crevice from line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial and distal (unit/tooth).&#xD;
Plaque index(PI, according to Silness and Löe, 1964): The total mean PI is the sum of the individual scores divided by the number of investigated sites. The thickness and extension of plaque were assessed (unit/tooth).&#xD;
Gingival index(GI, according to Löe, 1967): The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4 (unit/tooth).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Crowns (MeSH Unique ID: D003442), Single Tooth</condition>
  <condition>Dental Porcelain (MeSH Unique ID: D003776)</condition>
  <arm_group>
    <arm_group_label>Zirconium-reinforced glass ceramics (ZRGC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 posterior single tooth crowns made from monolithic zirconium-reinforced glass ceramics(ZRGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lithium disilicate glass ceramics (LGC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 2: 12 posterior single tooth crowns made from monolithic lithium disilicate glass ceramics(LGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resin infiltrated glass ceramics (RIGC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 posterior single tooth crowns made from monolithic resin infiltrated glass ceramics(RIGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)</intervention_name>
    <arm_group_label>Lithium disilicate glass ceramics (LGC)</arm_group_label>
    <arm_group_label>Resin infiltrated glass ceramics (RIGC)</arm_group_label>
    <arm_group_label>Zirconium-reinforced glass ceramics (ZRGC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old&#xD;
&#xD;
          -  Individuals who have signed the informed consent form&#xD;
&#xD;
          -  Periodontally stable patients&#xD;
&#xD;
          -  Having devital teeth need to be restored in the posterior region&#xD;
&#xD;
          -  Having natural dentition or minimally invasive restoration against the restored tooth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed patients with temporomandibular joint problems&#xD;
&#xD;
          -  Insufficient supportive tooth tissue for restoration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diler DENİZ, DDS, MSD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Instructor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Güliz AKTAŞ, DDS,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M.Barış GÜNCÜ, DDS,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Güliz N. GÜNCÜ, DDS,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Diler Deniz</investigator_full_name>
    <investigator_title>Clinical Instructor, Prosthetic Dentistry</investigator_title>
  </responsible_party>
  <keyword>Zirconium-reinforced glass ceramics(ZRGC)</keyword>
  <keyword>Lithium disilicate glass ceramics(LGC)</keyword>
  <keyword>Resin infiltrated glass ceramics(RIGC)</keyword>
  <keyword>Monolithic single tooth restoration</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lithium Carbonate</mesh_term>
  </intervention_browse>
  <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/NCT04474093
org study id: KA-16029
secondary id: THD-2016-11741
nct id: NCT04474093
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
With the development of Computer Aided Design and Computer Aided manufacturing (CAD / CAM)
      systems, all ceramic restorations have been used with high success rates during the past 30
      years in order to eliminate the disadvantages of metal ceramic restorations. Based on these
      developments, in every passing days new ceramic materials has been added to dental market.
      The aim of the present study was evaluating clinical results of single-tooth ceramic crowns
      in the posterior region produced from three different monolithic ceramic materials.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Survival rate and success (changes over time)
time frame: 1 year (Baseline to 12 months)
description: 12 crowns were made from each group of three different ceramics: ZRGC, LDGC and RIGC. Thereafter, the restorations was evaluated in terms of any failure or loss of the restoration at any follow-up (6th and 12th months) periods. The results were obtained proportionally in percent (%).
measure: Prosthetic evaluation changes
time frame: 1 year (Baseline to 12 months)
description: As recorded at the baseline (0), each restoration was assessed according to the modified the United States Public Health Service (USPHS) Ryge Criteria for prosthetic evaluation by a calibrated prosthodontics.USPHS criteria is based on the following ratings: Color match (Alpha,Bravo, Charlie), cavosurface marginal discoloration (Alpha,Bravo, Charlie), secondary caries (Alpha,Bravo), anatomic contour (Alpha,Bravo, Charlie), marginal integrity (Alpha,Bravo, Charlie), surface texture (Alpha,Bravo, Charlie) and gross fracture (Alpha,Bravo, Charlie).
measure: Periodontal evaluation changes
time frame: 1 year (Baseline to 12 months)
description: Probing depth(PD): Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket (mm).
Clinical attachment level(CAL): The loss of CAL were measured and calculated by measuring recession and subtracting the periodontal probing depth (mm).
Gingival bleeding time index(GBTI): The probe were swiped at apical portion of the gingival crevice from line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial and distal (unit/tooth).
Plaque index(PI, according to Silness and Löe, 1964): The total mean PI is the sum of the individual scores divided by the number of investigated sites. The thickness and extension of plaque were assessed (unit/tooth).
Gingival index(GI, according to Löe, 1967): The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4 (unit/tooth).
arm group label: Zirconium-reinforced glass ceramics (ZRGC)
arm group type: Active Comparator
description: 12 posterior single tooth crowns made from monolithic zirconium-reinforced glass ceramics(ZRGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation.
arm group label: Lithium disilicate glass ceramics (LGC)
arm group type: Active Comparator
description: Group 2: 12 posterior single tooth crowns made from monolithic lithium disilicate glass ceramics(LGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation.
arm group label: Resin infiltrated glass ceramics (RIGC)
arm group type: Active Comparator
description: 12 posterior single tooth crowns made from monolithic resin infiltrated glass ceramics(RIGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation.
intervention type: Other
intervention name: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)
arm group label: Lithium disilicate glass ceramics (LGC)
arm group label: Resin infiltrated glass ceramics (RIGC)
arm group label: Zirconium-reinforced glass ceramics (ZRGC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Diler DENİZ, DDS, MSD
role: Principal Investigator
affiliation: Clinical Instructor
last name: Güliz AKTAŞ, DDS,PhD
role: Study Director
affiliation: Associate Professor
last name: M.Barış GÜNCÜ, DDS,PhD
role: Study Chair
affiliation: Associate Professor
last name: Güliz N. GÜNCÜ, DDS,PhD
role: Study Chair
affiliation: Professor
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Diler Deniz
investigator title: Clinical Instructor, Prosthetic Dentistry
mesh term: Lithium Carbonate
sharing ipd: No