Comparison of Two Exercise Therapy Protocols in Patients With Bruxism

Bruxism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555628
• Other study ID #: 92340882-050.04.04
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: February 2024
• Source: Aydin Adnan Menderes University
• Contact: Gul Karabicak
• Phone: +90 2562138755
• Email: guloznur[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism

Intervention

Other:
• Mandibular Exercise
Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes
• Mandibular Exercise and Postural Exercise Group
Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes
• Occlusal Splint Group
Patients will use occlusal splints for 6 weeks. The occlusal splints will be used only sleep time.

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Faculty of Dentistry	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Agargün, M.Y., Kara, H., Anlar, Ö. (1996). The validity and reliability of the Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi, 7 (2), 107-115.

American Sleep Disorders Association. The International Classification of Sleep Disorders, Revised: Diagnostic and Coding Manual. Westchester, IL: American Academy of Sleep Medicine; 2005.

Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. — View Citation

Hazar Z, Karabicak GO, Tiftikci U. Reliability of photographic posture analysis of adolescents. J Phys Ther Sci. 2015 Oct;27(10):3123-6. doi: 10.1589/jpts.27.3123. Epub 2015 Oct 30. — View Citation

Markiewicz MR, Ohrbach R, McCall WD Jr. Oral behaviors checklist: reliability of performance in targeted waking-state behaviors. J Orofac Pain. 2006 Fall;20(4):306-16. — View Citation

Pintado MR, Anderson GC, DeLong R, Douglas WH. Variation in tooth wear in young adults over a two-year period. J Prosthet Dent. 1997 Mar;77(3):313-20. doi: 10.1016/s0022-3913(97)70189-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mandibular Motion	change in active mouth opening, lateral jaw movements and protrusion of mandible	baseline, 6 week, 12 week
Primary	Change in Pain level: pain intensity via Visual Analog Scale	Visual 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).	baseline, 6 week, 12 week
Primary	Change in Pain level: pain threshold.	Pressure 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.	baseline, 6 week, 12 week
Secondary	The Pittsburg Sleep Quality Index was used to assess sleep quality.	The 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 Agargün (1996) (2). The total score of the questionnaire ranges between 0 to 21. 5 points and more refers to bad sleep quality	baseline, 6 week, 12 week
Secondary	Oral Behaviours Checklist questionnaire was used to examine the oral habits of of the participants.	The 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).	baseline, 6 week, 12 week
Secondary	Postural alterations of the patients will be assessed by using the photographic method.	Within 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.	baseline, 6 week, 12 week