MedPath

Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders

Not Applicable
Completed
Conditions
Temporomandibular Joint Dysfunction Syndrome
Interventions
Radiation: Low Level LASER therapy
Device: Hard occlusal splint
Registration Number
NCT05901701
Lead Sponsor
Ain Shams University
Brief Summary

This study aimed to evaluate the sustainability of the efficacy of using low level laser therapy and CAD/CAM Michigan splint in improving the range of mandibular movements, muscle activity and reducing the pain.

Detailed Description

56 female patients were randomly divided into two groups, Group A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. Group B: Patients received hard occlusal splints (Michigan splints) of 2 mm thickness constructed on their upper teeth, the hard occlusal splint was 3D digitally printed. ARCUS digma facebow was used to evaluate the range of mandibular movements affected from TMJ problems. The opening measurements of the patient were taken using a millimeter ruler. Electromyogram (EMG) was used to evaluate muscle activity. Visual analogue scale (VAS) was used to evaluate the pain intensity. All was done before the beginning of the treatment at three and six months follow up period.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
56
Inclusion Criteria

tenderness in the TMJ or muscles of mastication (e.g., temporalis and masseter) that might get worse in the morning or with eating, headache, periauricular pain, teeth wear that appears in the form of multiple smooth shinny facets, teeth mobility, and malocclusion

Exclusion Criteria
  • pregnant females, breast feeders, patients having pacemakers, heart disease, tumors, general connective tissue disease e.g., Rheumatoid arthritis, psychiatric disorders, skeletal morphology as class II or III, TMJ clicking sounds, local skin infection over the masseter or temporalis, symptoms that may be referred to other disorders of orofacial region (tooth ache, trigeminal neuralgia, migraine), or patients using medications such as Muscle relaxant, Steroids, Dopamine precursors like L dopa and Aminoglycoside
  • Vulnerable groups (prisoners, mental disorders, patients not capable of decision making).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LASER groupLow Level LASER therapyGroup A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions.
Splint groupHard occlusal splintGroup B: Patients received hard occlusal splints (Michigan splints), used for 3 months during sleeping then the patient stops using it and told to only wear it if discomfort return usually during stressful times.
Primary Outcome Measures
NameTimeMethod
Electromyographic muscle activityMeasured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)

The change in muscle activity was assessed using EMG in terms of Microvolt

Range of mandibular movementMeasured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)

The increase in the range of movement measured using ARCUS digma in terms of angular inclination.

Secondary Outcome Measures
NameTimeMethod
Mouth openingMeasured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)

degree of mouth opening in cm using ruler

Pain intensityMeasured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)

The degree of pain is assessed using a 10 cm scale (VAS)

Trial Locations

Locations (1)

faculty of dentistry, Ain Shams University

🇪🇬

Cairo, Egypt

© Copyright 2025. All Rights Reserved by MedPath