Comparison of Two Exercise Therapy Protocols in Patients With Bruxism

NCT05555628 | Completed DMC

• 1 other identifier: 92340882-050.04.04
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Mandibular Motion

  change in active mouth opening, lateral jaw movements and protrusion of mandible

  baseline, 6 week, 12 week

• 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

• 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 Outcomes (3)

• The Pittsburg Sleep Quality Index was used to assess sleep quality.

  baseline, 6 week, 12 week

• Oral Behaviours Checklist questionnaire was used to examine the oral habits of of the participants.

  baseline, 6 week, 12 week

• Postural alterations of the patients will be assessed by using the photographic method.

  baseline, 6 week, 12 week

Study Arms (3)

Mandibular Exercise

EXPERIMENTAL

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.

Other: Mandibular Exercise

Mandibular and Postural Exercise

EXPERIMENTAL

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.

Other: Mandibular Exercise; Other: Mandibular Exercise and Postural Exercise Group

Occlusal Splint

ACTIVE COMPARATOR

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.

Other: Occlusal Splint Group

Interventions

Mandibular Exercise OTHER

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

Mandibular Exercise; Mandibular and Postural Exercise

Mandibular Exercise and Postural Exercise Group OTHER

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

Mandibular and Postural Exercise

Occlusal Splint Group OTHER

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

Occlusal Splint

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• age range
• 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);
• Pain around the jaw is 3 or more on the visual analog scale (7)
• Patients who volunteered to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Faculty of Dentistry

Aydin, 09010, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17190029 BACKGROUND

• 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.

  PMID: 26644658 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 9069087 BACKGROUND

• 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.

  PMID: 18467932 BACKGROUND

• Karabicak GO, Alkan Demetoglu G, Ozkan G, Gunaydin G, Onal Aykar S, Gunaydin OE. Jaw Exercise Versus Jaw & Posture Exercise Therapies in Comparison to Occlusal Splint Effectiveness in Probable Sleep Bruxism: A Randomised Controlled Study. J Oral Rehabil. 2025 Oct;52(10):1629-1640. doi: 10.1111/joor.14027. Epub 2025 May 14.

  PMID: 40369740 DERIVED

MeSH Terms

Conditions

Bruxism; Pain

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gul Karabicak, PhD

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd PT Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 27, 2022
• Study Start: July 15, 2022
• Primary Completion: February 15, 2024
• Study Completion: March 15, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

TU (1)