Comparison of Two Exercise Therapy Protocols in Patients With Bruxism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2024-03-15

Brief Summary

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The main purpose of this planned research is to investigate the effectiveness of three different methods used for the treatment of bruxism. Two of these are physiotherapy-specific exercise treatment protocols (1.posture and proprioception exercises 2. Jaw area strengthening exercises) and a control group, (occlusal splint therapy) will take place during the study.

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Detailed Description

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The current study is planned as a parallel group, randomized controlled trial. Patients who apply to Adnan Menderes University Faculty of Dentistry between June 2022 and January 2023 and diagnosed with bruxism after the examination will be screened for the study. Aydın Adnan Menderes University Faculty of Dentistry is a hospital that serves an average of 400 patients per day.

Conditions

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Bruxism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients in Groups I and II will be included in an exercise program that will last for 45 minutes, two days a week, for 6 weeks. All treatments will be carried out by a physiotherapist with more than 10 years of experience in the field. The patients will be treated independently from each other. The treatment protocols of the patients in exercise therapy group will be revised with 2-week controls, and their progress will be followed up with new exercises. Patients who do not come to two consequtive treatments to the treatment protocol will be excluded from the study.

Occlusal Splint Group; It will consist of two separate sessions, one week apart. It is aimed to eliminate possible incompatibilities by calling the patients for the control one week after the splints are delivered.

Assessments will be performed three times: prior to group assignment (baseline), immediately after the end of the treatment (week 6), and at the control of the 12th week.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Patients eligible to participate in the study will be assessed by a researcher who is blind to group assignment. The assessor will only see the patients during the evaluation. In this way, the masking of group assignment will be ensured.

Study Groups

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Mandibular Exercise

At the beginning of the treatment, the therapist will perform a soft tissue massage to the patient's muscles. Then, an exercise protocol for specific muscles (masseter, temporal muscles, mandibular region muscles) will be administered. This group, the exercise will focus only on the chin area, not general like posture.

Group Type EXPERIMENTAL

Mandibular Exercise

Intervention Type OTHER

Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes

Mandibular and Postural Exercise

The patients will perform posture exercises, including stabilization of the upper body and cervical region, accompanied by a physiotherapist. A theraband suitable for the patient's muscular strength will be used for posture exercises,. The appropriate therabant selection will be decided by a maximum repetition method.

Group Type EXPERIMENTAL

Mandibular Exercise

Intervention Type OTHER

Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes

Mandibular Exercise and Postural Exercise Group

Intervention Type OTHER

Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes

Occlusal Splint

The patients assigned to this group will be treated by the occlusal splint administered by the dentist and the recommendations that they should pay attention to in daily life.

Occlusal splints will be prepared according to previously published criteria by Okeson and other researchers. Occlusal splint measurement and production will be done by technicians with 5 years of experience. Using the models obtained from the maxillary measurements of the patients, 0.5 mm thick thermoplastic rigid splints will be prepared and adjusted according to the patient's occlusion. Occlusal splints will be prepared for night use only. Patients will use splints every night for 6 weeks. Splint use of the patients and possible side effects or plaque-related disorders will be followed up with phone calls to be made every 2 weeks.

Group Type ACTIVE_COMPARATOR

Occlusal Splint Group

Intervention Type OTHER

Patients will use occlusal splints for 6 weeks. The occlusal splints will be used only sleep time.

Interventions

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Mandibular Exercise

Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes

Intervention Type OTHER

Mandibular Exercise and Postural Exercise Group

Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes

Intervention Type OTHER

Occlusal Splint Group

Patients will use occlusal splints for 6 weeks. The occlusal splints will be used only sleep time.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of sleep Bruxism according to the criteria of the International Classification of Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM) (5);
2. 18-50 age range
3. The diagnosis of awake bruxism, which was determined by a positive answer to the questions of the questionnaire developed according to Pintado's recommendations (6);
4. Pain around the jaw is 3 or more on the visual analog scale (7)
5. Patients who volunteered to participate in the study

Exclusion Criteria

1. Systemic and/or degenerative disorders
2. Neurological or psychiatric diseases (excluding anxiety and depression)
3. Use of drugs that affect sleep or motor behavior
4. Arthrogenic or mixed temporomandibular disorder
5. Axis I myogenic TMD according to investigational diagnostic criteria for temporomandibular disorders (RDC/TMD)
6. Patients using total prosthesis
7. Direct trauma or previous surgical intervention in the orofacial region
8. Patients using muscle relaxants and non-steroidal anti-inflammatory drugs.
9. Patients using removable prostheses
10. Patients who have received any treatment for bruxism
11. Patients who did not want to participate in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No