Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

Study Overview
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Brief Summary
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The goal of this randomized controlled study is to compare laser acupuncture versus modified physical therapy in controlling bruxism in children. The main questions aim to answer are: Laser will decrease tempro-mandibular joint pain from bruxism more than modified physical therapy? Laser will decrease muscles activity from bruxism more than modified physical therapy? Children took 6 sessions of either laser acupuncture or modified physical therapy Researchers compared laser acupuncture versus modified physical therapy to see if any decrease in tempro-mandibular joint pain and muscles activity from bruxism

Detailed Description
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The children participated in the study as bruxers according to the American Association of Sleep Medicine (AASM) diagnostic criteria [ Sixteen children will be randomly allocated to two groups of 8 individuals each: Group one: laser acupuncture, Group two: electromyography biofeedback training. Pain will be measured by Visual Analogue scale; VAS (primary outcome)and muscle activity will be measured by Electromyography (Secondary outcome) of temporalis and masseter muscles. Measurements will be taken preoperatively and after 8 weeks.

Official Title
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Evaluation of Laser Acupuncture Versus Modified Physical Therapy Intervention in Management of Bruxism in Children, Study Protocol for a Randomized Controlled Study

Conditions
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Bruxism

Intervention / Treatment
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* Device: Laser acupuncture
* Behavioral: Modified physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Six to twelve years children Medically free Normal occlusion No or low caries experience Clinical dental wear Clenching or grinding reported by the parents Exclusion Criteria: Children with any physical or psychological disease. Children received any previous treatment for bruxism. Children with tempro-mandibular joint disorders

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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
Interventional Model Description: Randomized double arm controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser acupuncture<br>Laser acupuncture biostimulation for temporalis and masseter muscles | Device: Laser acupuncture<br>* Biostimulation of temporalis and masseter muscles<br>* Other names: Doctor smile low level laser device;|
| Experimental: Modified physical therapy<br>Muscle relaxation and biofeedback for temporalis and masseter muscles | Behavioral: Modified physical therapy<br>* Progressive muscle relaxation of temporalis and masseter muscles<br>* Other names: Relaxation and biofeedback of muscles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tempro-mandibular joint pain | Tenderness and pain of temporalis and masseter muscles by visual analogue scale (VAS) of pain before and after intervention either no pain, mild pain, moderate or severe pain. Better outcome means no or mild pain | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of temporalis and masseter muscles | Activity of temporalis and masseter muscles by surface electromyography (EMG) at rest and during function (Decrease in activity by small values bymicrons means better outcome and vice versa) | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bruxism, laser, children, Physiotherapy