Reduction of Masticatory Muscle Activity by Restoring Canine Guidance

Not Applicable

• Conditions: Muscular Activity; Bruxism; Myopathy
• Interventions: Other: Composite resin restoration

• Registration Number: NCT02235220
• Lead Sponsor: University of Kiel

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.

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-09
• Last Update Submitted: 2014-09-25
• Last Update Posted: 2014-09-26
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Composite resin restoration	Composite resin restoration	A canine guidance is reestablished by additive composite resin restorations of the canine cusp.

Primary Outcome Measures

Name	Time	Method
Reduction of masticatory muscular activity	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.