Effects of Low-Level Laser Therapy on Mouth Opening and Surface Electromyography in Temporomandibular Disorders

Not Applicable

Recruiting

• Conditions: Temporomandibular Joint Dysfunction Syndrome; Pain, Face

• Registration Number: NCT04831346
• Lead Sponsor: Cairo University

Brief Summary

This is a one year followup study that aims to assess the efficacy of low level laser therapy (LLLT) on pain, mouth opening and masticatory muscle activity in cases of temporomandibular dysfunction (TMD) as compared to soft occlusive splints.

Detailed Description

A prospective, parallel randomized, controlled study will be conducted at the outpatient university clinic. Participant recruitment started following approval from the Ethics Committee .The patients will participate in the study after signing an informed consent form prior to data collection. Per inclusion criteria, subjects included are females less than 30 years of age, diagnosed with unilateral arthrogenous TMD, having complete permanent dentition and showing normal occlusion. Prior to participating in any study-related procedures, participants read and signed the informed consent form approved by the Institutional Review Board. Participants will be divided into three groups; three groups: LLLT (Group A); soft occlusive splint therapy OST (Group B); waitlist as controls (Group C).

Outcome measures: TMJ opening index (TOI), VAS, sEMG. Participants were not given information on which treatment they were receiving; they were only told that they could receive one of two different treatment techniques. Sessions were scheduled 3 days a week (every other day) for a total of 10 sessions

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Females less than 30 years of age, Diagnosed with unilateral myogenous TMD, Having complete permanent dentition Showing normal occlusion

Exclusion Criteria

Prior experience of Laser therapy, Systemic diseases (rheumatoid arthritis, ankylosing spondylitis, diabetes... etc. History of trauma in the TMJ or cervical regions; Neurological disorders, Muscular diseases; Cervical pain; Bruxism, Pregnancy; Currently on medication (analgesic, anti-inflammatory, muscle relaxants or anti- depressants) Current use of dental prosthetics; Previous orthodontal treatments; or Fixed restorations affecting occlusal surfaces.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the Temporomandibular joint opening index (TOI):	baseline (pre-treatment) / after 3 weeks / and after 1 year	Active and passive mouth opening will be assessed by a Boley gauge (Electronic Digital Caliper, CE Company, Japan); TOI= Passive opening mm -Maximum voluntary opening mm X 100 Passive opening mm +Maximum voluntary opening mm

Secondary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale (VAS)	baseline (pre-treatment) / after 3 weeks / and after 1 year	The pain VAS is a reliable measure of pain intensity with a 10 centimeters (100 mm) continuous scale attached by 2 verbal descriptors, one for each symptom extreme.; For pain intensity, the scale is most anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100).; The VAS only requires the ability to use a ruler to measure the distance to determine a score.
change in surface EMG (sEMG):	baseline (pre-treatment) / after 3 weeks / and after 1 year	For recording, a surface electromyograph (Myotronics-Noromed, Inc., Tukwila WA, USA), with 8-channels, simultaneous acquisition, common grounding to all channels, and filters of 50 Hz electromyography with disposable electrodes will be used.; Subjects will be seated on chairs with back and head rests to allow assessment from a relaxed position.; The right masseter (RM), left masseter (LM), right anterior temporal (RAT), left anterior temporal (LAT), right sternocleidomastoid (RSM), and left sternocleidomastoid (LSM) muscles were recorded. The sEMG recordings and muscle activity will be expressed as the root mean square (rms) of the amplitude, expressed in µV.

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Egypt