Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism

NCT04884152 | Completed

• 1 other identifier: 2021/012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the effects of Home Exercise Therapy (HET) and Telerehabilitation in patients with myofascial temporomandibular disorders (TMD)with bruxism.

Conditions

Myofascial Pain; Temporomandibular Disorder; Bruxism

Keywords

Myofascial Pain; Temporomandibular Disorder; Bruxism; Telerehabilitation

Outcome Measures

Primary Outcomes (7)

• Change from Baseline in Pain at 4 weeks and 8 weeks

  Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 4 weeks intervention and at the end 8 weeks from baseline.

  Baseline, 4 weeks, 8 weeks

• Change from Baseline in Mandibular range of movements at 4 weeks and 8 weeks

  Maximum mouth opening, mandibular lateral right and left shift, and mandibular protrusion range of motion measurements in mm.

  Baseline, 4 weeks, 8 weeks

• Change from Baseline in Neck disability at 4 weeks and 8 weeks

  Neck Disability Index, consisting of a total of ten titles, was developed by Vernon and Mior in 1991. It includes topics such as pain intensity in the neck, personal care, lifting, reading, headaches, concentration, driving, sleep, and leisure activities. The maximum score is 50, while the minimum is 0 points. Classification according to total score is as follows: 0-4 (no restrictions); 5-14 (mild restriction); 15-24 (moderate restriction); 25-34 (severe limitation); 34 and above (completely limited).

  Baseline, 4 weeks, 8 weeks

• Change from Baseline in Headache at 4 weeks and 8 weeks

  Headache Impact Test-6 test consists of 6 questions about the severity of headache, the effect of pain on daily life activities, how often it causes fatigue and low motivation, and concentration impairment. Scoring is done between 36-78.

  Baseline, 4 weeks, 8 weeks

• Change from Baseline in Sleep Quality at 4 weeks and 8 weeks

  Pittsburg Sleep Quality Index test is used to evaluate sleep effects in the last few months. This questionnaire contains 24 questions, 19 of which are personal, and 5 of which are to be answered by a partner about sleep during both day and night. Five questions answered by the partner are not included in the scoring. Self-assessment questions contain different items related to sleep quality, which provide information about sleep duration, latency, and the frequency and severity of specific sleep problems. The total score is between 0-21. A score of 5 and below indicates good sleep quality, and a score above 5 indicates poor sleep quality.

  Baseline, 4 weeks, 8 weeks

• Change from Baseline in Oral Behavior at 4 weeks and 8 weeks

  Evaluation of oral habits with the Oral Habits Questionnaire consisting of 21 items, each item was evaluated according to the frequency of complaints as "4 = always; 3 = most of the time; 2 = sometimes; 1 = several times or 0 = none". The questions cover the times of sleep and wakefulness. The overall score ranges from 0 to 84.

  Baseline, 4 weeks, 8 weeks

• Change from Baseline in Quality of life at 4 weeks and 8 weeks

  The individual's personal perception of how oral health affects their quality of life and general health is measured. Oral Health Impact Profile-14 is a scale system that evaluates this perception with questions for functional limitation, physical pain, psychological discomfort, physical, psychological and social inadequacy, and disability measures. It is concluded that as the total score increases, the severity of the problem increases, and the quality of life decreases.

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (3)

• Change from Baseline in Head and Shoulder Posture at 4 weeks and 8 weeks

  Baseline, 4 weeks, 8 weeks

• Change from Baseline in Anxiety at 4 weeks and 8 weeks

  Baseline, 4 weeks, 8 weeks

• Change from Baseline in Fatigue at 4 weeks and 8 weeks

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Home Exercise Group

ACTIVE COMPARATOR

The home Exercise program includes an educational training program about parafunctional activities of patients having bruxism with myofascial temporomandibular disorders. The program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises. Relaxation: Relaxation exercises with diaphragmatic breathing Posture Exercise: Rest position of tongue and TMJ, head and neck posture correction exercises Stretching Exercises: Stretching exercises for chewing muscles, cervical muscles, and pectoral muscles Strengthening: The neck will consist of strengthening exercises for deep flexor muscles, suprahyoid and infrahyoid muscles, and scapular retractors.

Procedure: Home Exercise Group

Telerehabilitation Group

EXPERIMENTAL

The program includes the same stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises using telerehabilitation once a week by video call, and reminder messages will be sent to the patients 3 times a week. Relaxation: Relaxation exercises with diaphragmatic breathing Posture Exercise: Rest position of tongue and TMJ, head and neck posture correction exercises Stretching Exercises: Stretching exercises for chewing muscles, cervical muscles, and pectoral muscles Strengthening: The neck will consist of strengthening exercises for deep flexor muscles, suprahyoid and infrahyoid muscles, and scapular retractors.

Procedure: Telerehabilitation Group

Interventions

Home Exercise Group PROCEDURE

Educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.

Home Exercise Group

Telerehabilitation Group PROCEDURE

Telerehabilitation program combined with educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.

Telerehabilitation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages between 18 and 65 years old
• Patients with TMD in the myofascial Group Ia, Ib according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and diagnosed with bruxism
• Having pain ≥ 3 according to the Visual Analog Scale
• Those who have not received medical treatment for the last 3 months and will not receive it during the treatment process will be included in the study.

You may not qualify if:

• Ages under 18 and over 65 years old
• Patients with disc displacement and/or TMJ degeneration
• Patients who have orthodontic or splint treatment
• Patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and/or temporomandibular joint (TMJ) problem malignancy, fracture, the rheumatoid disease is proven
• Patients who have undergone any surgery related to the cervical and/or TMJ
• Patients with facial paralysis
• Patients who regularly use analgesic or anti-inflammatory drugs
• Patients who have received physical therapy associated with TMJ in less than 3 months
• Patients with a history of trauma (whiplash injury, condylar trauma, fracture)
• Patients with cognitive deficits
• Participation rate lower than 80% of the program schedule

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior

Study Officials

• Aysenur Tuncer

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: May 3, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 30, 2022
• Last Updated: January 10, 2024

Record last verified: 2022-08

Locations

TU (1)