<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/NCT03039985</url>
  </required_header>
  <id_info>
    <org_study_id>SCHM2456/4-1</org_study_id>
    <nct_id>NCT03039985</nct_id>
  </id_info>
  <brief_title>All-ceramic Crowns in Patients With Sleep Bruxism</brief_title>
  <official_title>All-ceramic Crowns in Patients With Sleep Bruxism - a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Heidelberg University</source>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the complication rate of 2 types of all-ceramic crowns in&#xD;
      patients with or without bruxism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">November 2, 2022</completion_date>
  <primary_completion_date type="Actual">November 2, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success of all-ceramic crowns as determined by complication rate</measure>
    <time_frame>up to 5 years</time_frame>
    <description>In this study, a complication is defined as any event happening at the study crown or the supporting tooth that requires a clinical intervention.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Sleep Bruxism</condition>
  <condition>Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns)</condition>
  <arm_group>
    <arm_group_label>Bruxism + lithium disilicate crown</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant with sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No bruxism + lithium disilicate crown</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant without sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bruxism + zirconia crown</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant with sleep bruxism receives a monolithic molar crown manufactured from zirconia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No bruxism + zirconia crown</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant without sleep bruxism receives a monolithic molar crown manufactured from zirconia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zirconia crowns (Prettau®)</intervention_name>
    <description>Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism</description>
    <arm_group_label>Bruxism + zirconia crown</arm_group_label>
    <arm_group_label>No bruxism + zirconia crown</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lithium disilicate crowns (IPSe.max®)</intervention_name>
    <description>lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism</description>
    <arm_group_label>Bruxism + lithium disilicate crown</arm_group_label>
    <arm_group_label>No bruxism + lithium disilicate crown</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  need a molar crown&#xD;
&#xD;
          -  tooth antagonist (no implant)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no Antagonist pregnancy, bleeding, periodontal diseases&#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>Brigitte Ohlmann, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heidelberg University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc Schmitter, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Würzburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Prosthodontics, University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heidelberg University</investigator_affiliation>
    <investigator_full_name>Brigitte Ohlmann</investigator_full_name>
    <investigator_title>Prof. Dr. med.dent.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bruxism</mesh_term>
    <mesh_term>Sleep Bruxism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lithium Carbonate</mesh_term>
  </intervention_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/NCT03039985
org study id: SCHM2456/4-1
nct id: NCT03039985
lead sponsor: 
collaborator: 
The aim of the study is to evaluate the complication rate of 2 types of all-ceramic crowns in
      patients with or without bruxism.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Success of all-ceramic crowns as determined by complication rate
time frame: up to 5 years
description: In this study, a complication is defined as any event happening at the study crown or the supporting tooth that requires a clinical intervention.
arm group label: Bruxism + lithium disilicate crown
arm group type: Experimental
description: Participant with sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.
arm group label: No bruxism + lithium disilicate crown
arm group type: Experimental
description: Participant without sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.
arm group label: Bruxism + zirconia crown
arm group type: Experimental
description: Participant with sleep bruxism receives a monolithic molar crown manufactured from zirconia.
arm group label: No bruxism + zirconia crown
arm group type: Experimental
description: Participant without sleep bruxism receives a monolithic molar crown manufactured from zirconia.
intervention type: Device
intervention name: Zirconia crowns (Prettau®)
description: Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism
arm group label: Bruxism + zirconia crown
arm group label: No bruxism + zirconia crown
intervention type: Device
intervention name: lithium disilicate crowns (IPSe.max®)
description: lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism
arm group label: Bruxism + lithium disilicate crown
arm group label: No bruxism + lithium disilicate crown
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brigitte Ohlmann, Prof. Dr.
role: Principal Investigator
affiliation: Heidelberg University
last name: Marc Schmitter, Prof. Dr.
role: Principal Investigator
affiliation: University of Würzburg
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heidelberg University
investigator full name: Brigitte Ohlmann
investigator title: Prof. Dr. med.dent.
mesh term: Bruxism
mesh term: Sleep Bruxism
mesh term: Lithium Carbonate