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NCT Number: NCT05555628

Comparison of Two Exercise Therapy Protocols in Patients With Bruxism

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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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adnan Menderes University Faculty of Dentistry

Aydin, 09010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • 18-50 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

Exclusion criteria

  • 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

Treatment and study plan

Mandibular Exercise

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

Other

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

Occlusal Splint Group

Other

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

Primary outcomes

  1. Mandibular Motion

    Time frame: baseline, 6 week, 12 week

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

  2. Change in Pain level: pain intensity via Visual Analog Scale

    Time frame: baseline, 6 week, 12 week

    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).

  3. Change in Pain level: pain threshold.

    Time frame: baseline, 6 week, 12 week

    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.

Secondary outcomes

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

    Time frame: baseline, 6 week, 12 week

    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 Ağargün (1996) (2). The total score of the questionnaire ranges between 0 to 21. 5 points and more refers to bad sleep quality

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

    Time frame: baseline, 6 week, 12 week

    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).

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

    Time frame: baseline, 6 week, 12 week

    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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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