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Clinical Trials/NCT05555628
NCT05555628
Completed
Not Applicable

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

Aydin Adnan Menderes University1 site in 1 country21 target enrollmentJuly 15, 2022
ConditionsBruxism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bruxism
Sponsor
Aydin Adnan Menderes University
Enrollment
21
Locations
1
Primary Endpoint
Mandibular Motion
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
March 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aydin Adnan Menderes University
Responsible Party
Principal Investigator
Principal Investigator

GulOznur KARABICAK

Phd PT Principal Investigator

Aydin Adnan Menderes University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mandibular Motion

Time Frame: baseline, 6 week, 12 week

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

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.

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).

Secondary Outcomes

  • Postural alterations of the patients will be assessed by using the photographic method.(baseline, 6 week, 12 week)
  • 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)

Study Sites (1)

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