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Comparison of Two Exercise Therapy Protocols in Patients With Bruxism

Comparison of Two Exercise Therapy Protocols in Patients With Bruxism: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05555628
Enrollment
21
Registered
2022-09-27
Start date
2022-07-15
Completion date
2024-03-15
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism

Keywords

bruxism, physiotherapy, exercise therapy, occlusal splint, pain, rehabilitation

Brief summary

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.

Detailed description

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.

Interventions

OTHERMandibular Exercise

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

OTHERMandibular Exercise and Postural Exercise Group

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

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

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mandibular Motionbaseline, 6 week, 12 weekchange in active mouth opening, lateral jaw movements and protrusion of mandible
Change in Pain level: pain intensity via Visual Analog Scalebaseline, 6 week, 12 weekVisual analog scale will be used for the change in pain severity. In a straight line adjusted to 10 cm, the patient is asked to mark the intensity of pain felt at the moment on jaw area. A value of 0 is used to describe the absence of pain, and a value of 10 to describe an unbearable pain. Patients will be asked to rate their pain at the time of assessment (not in the past week or month).
Change in Pain level: pain threshold.baseline, 6 week, 12 weekPressure algometry will be used to assess the pain threshold. This device, which has a pressure area of 1 cm in diameter, shows the applied pressure objectively. The pressure algometer, will be applied by pressing the patient's trigger points (masseter, temporal, trapezius muscles) at an angle of 90 degrees, is calculated by recording the pressure that occurs when the person expresses that he/she feels the pain for the first time. The patient will be positioned seated. The average of the three measurement results to be made is recorded as an evaluation.

Secondary

MeasureTime frameDescription
The Pittsburg Sleep Quality Index was used to assess sleep quality.baseline, 6 week, 12 weekThe Pittsburg Sleep Quality Index was developed by Buysse et al. (1989) to evaluate sleep quality in psychiatry practices and clinical studies (1). The items in the PUKI were arranged using clinical observations of patients with sleep disorders, other scales related to sleep quality mentioned in the literature, and an 18-month clinical observation period related to The Pittsburg Sleep Quality Index. The Turkish validity and reliability study of this scale was carried out by Ağargün (1996) (2). The total score of the questionnaire ranges between 0 to 21. 5 points and more refers to bad sleep quality
Oral Behaviours Checklist questionnaire was used to examine the oral habits of of the participants.baseline, 6 week, 12 weekThe questionnaire, which questions how often parafunctional habits such as clenching, grinding, nail, lip, cheek, pencil biting, gum chewing have been done in the last month, is answered with a 4-point Likert scale. The total score of the the Oral Behaviours Checklist will be used for the analyses. A person's overall score can range from 0 to 84. The validity and reliability of the questionnaire has been demonstrated within the scope of the RDC/TMD Validation project (3).
Postural alterations of the patients will be assessed by using the photographic method.baseline, 6 week, 12 weekWithin the scope of the evaluation, craniovertebral and craniocervical angles will be evaluated. For this purpose, an silence environment where the patients are comfortable will be provided, and photographs will be taken from the same lateral direction with the help of a camera located on a triple stand 1.5m away, fixed at a height of 115cm. All necessary procedure explanations are available in the relevant resource (4). With this method, an objective numerical data is obtained for the evaluation of cervical posture.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026