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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
Sponsor:
Information provided by (Responsible Party):
Martin Sasse, 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.

Condition or disease Intervention/treatment Phase
Bruxism Myopathy Muscular Activity Other: Composite resin restoration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Kiel
Investigators
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Study Director: Matthias Kern, DDS, PhD University of Kiel

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Responsible Party: Martin Sasse, Dr. Martin Sasse, D.M.D, Assistant Professor, University of Kiel
ClinicalTrials.gov Identifier: NCT02235220     History of Changes
Other Study ID Numbers: Canine guidance / Grindcare
D 432/12 ( Other Identifier: Ethics Commission University of Kiel, Germany )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014
Keywords provided by Martin Sasse, University of Kiel:
Bruxism
Additional relevant MeSH terms:
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Bruxism
Tooth Diseases
Stomatognathic Diseases