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
About this trial
This is an interventional treatment trial for Bruxism focused on measuring Bruxism
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
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
NCT ID
NCT02235220
First Posted
September 4, 2014
Last Updated
September 25, 2014
Sponsor
University of Kiel
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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