Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism

Temporomandibular Disorder Clinical Trial

Official title:

Investigation of the Effectiveness of Telerehabilitation in Individuals Myofascial Temporomandibular Dysfunction With Bruxism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884152
• Other study ID #: 2021/012
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2022
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Home Exercise will be Group 1 and Telerehabilitation group will be Group 2. Group 1 HET, will include an educational training program about parafunctional activities of TMD disorders and bruxism and active exercises for 4 weeks. As part of the Home exercise program, a written document will be prepared, including relaxation, breathing training, posture, stretching, and strengthening exercises to be given to the patients. Group 2, in addition to the training and written document, the second group will receive the same exercises using telerehabilitation once a week by video call, and reminder messages will be sent to the patients 3 times a week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bruxism
• Myofascial Pain
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Home Exercise Group
Educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.
• Telerehabilitation Group
Telerehabilitation program combined with educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change from Baseline in Head and Shoulder Posture at 4 weeks and 8 weeks	Forward Head Posture: The angle between the C7-Ear-Horizontal plane in the sitting position (in degrees with a goniometer) Shoulder Posture: The angle between the Acromion-C7-Horizontal Plane in the sitting position (in degrees with a goniometer).	Baseline, 4 weeks, 8 weeks
Secondary	Change from Baseline in Anxiety at 4 weeks and 8 weeks	The State-Trait Anxiety Inventory was developed by Spielberger et al. to measure state anxiety and trait anxiety. The questionnaire consists of 40 questions, the expressions used by the person in expressing his own feelings were included. There are four categories (nothing-a little-much-completely) for answers.	Baseline, 4 weeks, 8 weeks
Secondary	Change from Baseline in Fatigue at 4 weeks and 8 weeks	The Fatigue Severity Scale is used to measure the severity of fatigue in the past week, including today. The questionnaire consists of 9 items in total, and participants are asked to give a score from 1 to 7 for each question. The fatigue level of the patient is determined according to the score obtained by the sum of the points. The higher the level of fatigue, the higher the total score.	Baseline, 4 weeks, 8 weeks