The Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis

Study Overview
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Brief Summary
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Temporomandibular disorder (TMD) is the major cause of nondental pain in orofacial area. Laser therapy can be considered as one of the most popular methods of pain relief in TMD patients. The special features of laser light such as coherence, monochromaticity, and collimation can result in the ability of laser light to modify cellular metabolism, increase tissue repair and reduce edema and inflammation. The effectiveness of low level laser therapy in reducing the signs and symptoms of temporomandibular joint disorders has been investigated in a few studies. But, in most of the previous studies the etiology of TMD has not been considered in patient selection. Furthermore, there are some controversies in the results of these studies. According to our data, there is no study evaluating the effects of low level laser therapy on patients having TMJ osteoarthritis. The aim of this study is to evaluate the effectiveness of low level laser therapy in improving osteoarthritis of temporomandibular joint and also to evaluate the long term effects of laser therapy on the morphology of the joint.

Detailed Description
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Project method: This study will be implemented on 20 patients aged 35-60 years referring to Department of Prosthetic Dentistry of Mashhad Dental School. The patients are selected according to the RDC/TMD criteria to include those having temporomandibular osteoarthritis with unknown etiology. The patients will be asked to take cone beam CT of temporomandibular joint to evaluate any changes in morphology of the TMJ. The patients will be randomly assigned to two groups: Group 1 (treatment group) will receive low level laser therapy. The laser light will be applied with 890 nm diode laser (Mustang 2000+, Russia) with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the joint area and painful muscles if any. In Group 2 (placebo) the low power laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects. Laser therapy for both the treatment and placebo groups will be applied in the back, front, and above the mandibular condyles and inside the external auditory meatus and also on painful muscles three times a week for four weeks. Patients will be evaluated at the start of the treatment, after the 6th and 12th sessions of laser therapy and also one month after the end of the treatment. At each evaluation, the pain level in opening the mouth and masticatory muscle tenderness will be measured according to the Visual Analogue Scale (VAS). The range of lateral and protrusive mandibular movements, the difficulty in chewing food and the the presence or absence of sound joints will also be evaluated. One year after treatment, the patients will be referred for taking the second cone beam CT of the TMJ to seek any change in morphology of the joint.

Official Title
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A Randomized Clinical Trial of the Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis

Conditions
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Temporomandibular Joint Disorder

Intervention / Treatment
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* Radiation: Low level laser therapy
* Radiation: Low level laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients are selected according to the RDC/TMD criteria to include those having temporomandibular osteoarthritis with unknown etiology. Exclusion Criteria: Patients with systemic problems. Patients using analgesic or antidepressant drugs. Patients undergoing any treatment modality for TMD disease.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laser<br>In this group, the 890 nm diode laser (Mustang 2000+,Russia) will be used with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the joint area and painful muscles if any. | Radiation: Low level laser therapy<br>* In this group, the 890 nm diode laser (Mustang 2000+, Russia) will be applied with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the joint area and painful muscles if any.<br>* Other names: low power laser, laser therapy, diode laser;|
| Placebo Comparator: placebo<br>In this group the low power laser will be applied with minimal dose that is very lower than the threshold necessary for therapeutic effects. | Radiation: Low level laser therapy<br>* In this group, the low level laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects.<br>* Other names: low power laser, laser therapy, diode laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Pain is assessed by visual analogue scale (VAS) | Up to 1 month after laser theray | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMD sounds | The presence or absence of articular sounds is checked. | Up to 1 month after laser therapy | 
| Mouth opening measurement | The amount of mouth opening with and without pain is measured. | Up to 1 month after laser therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular disorder, laser therapy, osteoarthritis