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Reduction of Masticatory Muscle Activity by Restoring Canine Guidance

Primary Purpose

Bruxism, Myopathy, Muscular Activity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Composite resin restoration
Sponsored by
University of Kiel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruxism focused on measuring Bruxism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients show signs of bruxism
  • no canine guidance is present
  • no prosthodontic restorations of the canine are present

Exclusion Criteria:

  • a sufficient canine guidance is present

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Composite resin restoration

    Arm Description

    A canine guidance is reestablished by additive composite resin restorations of the canine cusp.

    Outcomes

    Primary Outcome Measures

    Reduction of masticatory muscular activity
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2014
    Last Updated
    September 25, 2014
    Sponsor
    University of Kiel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02235220
    Brief Title
    Reduction of Masticatory Muscle Activity by Restoring Canine Guidance
    Official Title
    Reduction of Masticatory Muscle Activity by Restoring Canine Guidance With Composite Resin Fillings in Patients With Bruxism.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Kiel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bruxism, Myopathy, Muscular Activity
    Keywords
    Bruxism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Composite resin restoration
    Arm Type
    Experimental
    Arm Description
    A canine guidance is reestablished by additive composite resin restorations of the canine cusp.
    Intervention Type
    Other
    Intervention Name(s)
    Composite resin restoration
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Reduction of masticatory muscular activity
    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.
    Time Frame
    13 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients show signs of bruxism no canine guidance is present no prosthodontic restorations of the canine are present Exclusion Criteria: a sufficient canine guidance is present
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthias Kern, DDS, PhD
    Organizational Affiliation
    University of Kiel
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Reduction of Masticatory Muscle Activity by Restoring Canine Guidance

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