<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/NCT02235220</url>
  </required_header>
  <id_info>
    <org_study_id>Canine guidance / Grindcare</org_study_id>
    <secondary_id>D 432/12</secondary_id>
    <nct_id>NCT02235220</nct_id>
  </id_info>
  <brief_title>Reduction of Masticatory Muscle Activity by Restoring Canine Guidance</brief_title>
  <official_title>Reduction of Masticatory Muscle Activity by Restoring Canine Guidance With Composite Resin Fillings in Patients With Bruxism.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kiel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kiel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study it is to be evaluated wether a restoration with composite resin fillings to&#xD;
      reestablish a canine guidance will reduce masticatory muscle activity in patients with&#xD;
      bruxism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 patients showing clinical symptoms of bruxism receive treatment within this clinical&#xD;
      trial. Typical symptoms like pain or tenseness of the masticatory muscles, headache or&#xD;
      abrasions are mandatory preconditions. Exclusion criteria are a present treatment with a&#xD;
      biteguard or a sufficient canine guidance.&#xD;
&#xD;
      In the first session a detailed history, a dental status and a clinical functional status are&#xD;
      recorded. The baseline situation is documented by taking impressions with alginate of the&#xD;
      maxilla and mandible for diagnostic study models. Following this procedure a first&#xD;
      measurement of the muscular activity is conducted for seven days with the Grindcare device.&#xD;
&#xD;
      After four weeks without any intervention a second measurement is conducted again for seven&#xD;
      days.&#xD;
&#xD;
      In the next session the canine cusps are restored with composite fillings. Finally a&#xD;
      sufficient canine guidance should be present. In the same session a second impression of the&#xD;
      maxilla is taken. A third measurement is conducted, again followed by four weeks without any&#xD;
      intervention.&#xD;
&#xD;
      At last another impression of the maxilla is obtained and a final measurement for seven days&#xD;
      is conducted.&#xD;
&#xD;
      At the first examination and after the third measurement of the masticatory muscle activity&#xD;
      the patients fill out the questionnaire of the Oral Health Impact Profile in order to allow&#xD;
      for the assessment of possible functional restraints and mental interferences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of masticatory muscular activity</measure>
    <time_frame>13 weeks</time_frame>
    <description>Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Bruxism</condition>
  <condition>Myopathy</condition>
  <condition>Muscular Activity</condition>
  <arm_group>
    <arm_group_label>Composite resin restoration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A canine guidance is reestablished by additive composite resin restorations of the canine cusp.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Composite resin restoration</intervention_name>
    <description>Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity.&#xD;
A first measurement is conducted, followed by 4 weeks without any intervention. A second measurement is then carried out before restoration of the canine cusps with composite fillings. A third measurement is conducted, again followed by 4 weeks without any intervention. At last a final measurement is conducted.</description>
    <arm_group_label>Composite resin restoration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients show signs of bruxism&#xD;
&#xD;
          -  no canine guidance is present&#xD;
&#xD;
          -  no prosthodontic restorations of the canine are present&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a sufficient canine guidance is present&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Kern, DDS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Kiel</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kiel</investigator_affiliation>
    <investigator_full_name>Martin Sasse</investigator_full_name>
    <investigator_title>Dr. Martin Sasse, D.M.D, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Bruxism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bruxism</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/NCT02235220
org study id: Canine guidance / Grindcare
secondary id: D 432/12
nct id: NCT02235220
lead sponsor: 
has dmc: No
In this study it is to be evaluated wether a restoration with composite resin fillings to
      reestablish a canine guidance will reduce masticatory muscle activity in patients with
      bruxism.
30 patients showing clinical symptoms of bruxism receive treatment within this clinical
      trial. Typical symptoms like pain or tenseness of the masticatory muscles, headache or
      abrasions are mandatory preconditions. Exclusion criteria are a present treatment with a
      biteguard or a sufficient canine guidance.

      In the first session a detailed history, a dental status and a clinical functional status are
      recorded. The baseline situation is documented by taking impressions with alginate of the
      maxilla and mandible for diagnostic study models. Following this procedure a first
      measurement of the muscular activity is conducted for seven days with the Grindcare device.

      After four weeks without any intervention a second measurement is conducted again for seven
      days.

      In the next session the canine cusps are restored with composite fillings. Finally a
      sufficient canine guidance should be present. In the same session a second impression of the
      maxilla is taken. A third measurement is conducted, again followed by four weeks without any
      intervention.

      At last another impression of the maxilla is obtained and a final measurement for seven days
      is conducted.

      At the first examination and after the third measurement of the masticatory muscle activity
      the patients fill out the questionnaire of the Oral Health Impact Profile in order to allow
      for the assessment of possible functional restraints and mental interferences.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of masticatory muscular activity
time frame: 13 weeks
description: Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity.
arm group label: Composite resin restoration
arm group type: Experimental
description: A canine guidance is reestablished by additive composite resin restorations of the canine cusp.
intervention type: Other
intervention name: Composite resin restoration
description: Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity.
A first measurement is conducted, followed by 4 weeks without any intervention. A second measurement is then carried out before restoration of the canine cusps with composite fillings. A third measurement is conducted, again followed by 4 weeks without any intervention. At last a final measurement is conducted.
arm group label: Composite resin restoration
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias Kern, DDS, PhD
role: Study Director
affiliation: University of Kiel
responsible party type: Principal Investigator
investigator affiliation: University of Kiel
investigator full name: Martin Sasse
investigator title: Dr. Martin Sasse, D.M.D, Assistant Professor
mesh term: Bruxism