Clinical trial NCT05555628: Comparison of Two Exercise Therapy Protocols in Patients With Bruxism
Official title: Comparison of Two Exercise Therapy Protocols in Patients With Bruxism: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism
Keywords: bruxism
physiotherapy
exercise therapy
occlusal splint
pain
rehabilitation
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mandibular Motion
timeFrame: baseline, 6 week, 12 week
measure: Change in Pain level: pain intensity via Visual Analog Scale
timeFrame: baseline, 6 week, 12 week
measure: Change in Pain level: pain threshold.
timeFrame: baseline, 6 week, 12 week
Secondary outcomes:
measure: The Pittsburg Sleep Quality Index was used to assess sleep quality.
timeFrame: baseline, 6 week, 12 week
measure: Oral Behaviours Checklist questionnaire was used to examine the oral habits of of the participants.
timeFrame: baseline, 6 week, 12 week
measure: Postural alterations of the patients will be assessed by using the photographic method.
timeFrame: baseline, 6 week, 12 week
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Faculty of Dentistry
Study officials:
affiliation: Aydin Adnan Menderes University
name: Gul Karabicak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Ağargün, M.Y., Kara, H., Anlar, Ö. (1996). The validity and reliability of the Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi, 7 (2), 107-115.
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.
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.
citation: American Sleep Disorders Association. The International Classification of Sleep Disorders, Revised: Diagnostic and Coding Manual. Westchester, IL: American Academy of Sleep Medicine; 2005.
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.
citation: 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.