Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders (RCT)

Ain Shams University

Status: Completed

Conditions: Temporomandibular Joint Dysfunction Syndrome

Treatments: Radiation: Low Level LASER therapy; Device: Hard occlusal splint

Study type: Interventional

Funder types: Other

Identifiers

NCT05901701

FDASU-Rec IR112207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

LASER group

Experimental group

Description:

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.

Treatment:

Radiation: Low Level LASER therapy

Splint group

Active Comparator group

Description:

Group 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.

Treatment:

Device: Hard occlusal splint