Reduction of Masticatory Muscle Activity by Restoring Canine Guidance
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|ClinicalTrials.gov Identifier: NCT02235220|
Recruitment Status : Unknown
Verified September 2014 by Martin Sasse, University of Kiel.
Recruitment status was: Enrolling by invitation
First Posted : September 9, 2014
Last Update Posted : September 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bruxism Myopathy Muscular Activity||Other: Composite resin restoration||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduction of Masticatory Muscle Activity by Restoring Canine Guidance With Composite Resin Fillings in Patients With Bruxism.|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Composite resin restoration
A canine guidance is reestablished by additive composite resin restorations of the canine cusp.
Other: Composite resin restoration
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.
- Reduction of masticatory muscular activity [ Time Frame: 13 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235220
|Study Director:||Matthias Kern, DDS, PhD||University of Kiel|