Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Low-Level Laser Therapy Versus CAD/CAM Michigan Splint on Patients With Temporomandibular Muscle Disorders Randomized Clinical Trial

Conditions
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Temporomandibular Joint Dysfunction Syndrome

Intervention / Treatment
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* Radiation: Low Level LASER therapy
* Device: Hard occlusal splint


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A: Patients received applications of low-level laser therapy. Group B: Patients received hard occlusal splints (Michigan splints).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LASER group<br>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. | Radiation: Low Level LASER therapy<br>* using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions.<br>|
| Active Comparator: Splint group<br>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. | Device: Hard occlusal splint<br>* 2 mm thickness occlusal splint constructed over the maxillary arch using CAD/CAM technology.<br>* Other names: Michigan splint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyographic muscle activity | The change in muscle activity was assessed using EMG in terms of Microvolt | Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months) | 
| Range of mandibular movement | The increase in the range of movement measured using ARCUS digma in terms of angular inclination. | Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | The degree of pain is assessed using a 10 cm scale (VAS) | Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months) | 
| Mouth opening | degree of mouth opening in cm using ruler | Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low level LASER therapy, Michigan splint, Electromyogram, Myofascial pain