Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction

Study Overview
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Brief Summary
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comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.

Detailed Description
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to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation period.

Official Title
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Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Device: Laser therapy
* Device: anterior re-positioning splint
* Device: inactive Laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having TMD in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the MRI. Good general health: The patient must be medically free from any systemic disease or health problems. Adult patients 18 years old and above. No previous orthodontic treatment. No previous TMJ treatment or surgery. Exclusion Criteria: Patients with multiple missing posterior teeth. Muscle pain due to systemic disease. Dental related pain. Congenital abnormality, neoplasia or acute trauma. Previous TMJ treatment or surgery. Any medical condition that prohibits MRI acquisition.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser therapy<br>12 laser sessions over 3 months | Device: Laser therapy<br>* epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.<br>* Other names: Biolase laser device;|
| Active Comparator: anterior re-positioning splint therapy<br>anterior re-positioning splint worn for 8 hours during night time for 3 months | Device: anterior re-positioning splint<br>* hard acrylic anterior re-positioning splint<br>* Other names: TMD splint;|
| Placebo Comparator: inactive laser therapy<br>placebo laser for 12 sessions over 3 months | Device: inactive Laser therapy<br>* sham Laser, with inactive beam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of temporomandibular joint pain: assessed by using subjective visual analogue scale | current level of temporomandibular joint pain assessed by using subjective visual analogue scale from 1 to 10 according to the research diagnostic criteria of temporomandibular disorders diagnostic sheets, zero indicates no pain, while 10 indicates the worst pain | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| click: joint sound | joint sound., it is a binary measurement assessed by hand palpation | 3 months | 
| limitation of mandibular movements | mouth opening, measured between the incisal edges of upper and lower incisors using a digital caliper, right and left mandibular movements, measured from upper dental midline to lower dental midline using a digital caliper. | 3 months | 
| disc recapture | change in articular disc morphology and configuration using two dimensional measurements on a DICOM viewer software including both linear and angular measurements in relation to cartesian coordinates X and Y | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser therapy, anterior re-positioning splint