Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction

Study Overview
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Brief Summary
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Stabilization splint therapy and Low-level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low-level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low- level laser therapy, group II received low - level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention.

Detailed Description
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Objectives: Stabilization splint therapy and low- level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low- level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction. Patients and methods: 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low-level laser therapy, group II received low-level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention. Time of being normal was also evaluated.

Official Title
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Comparison Between the Efficacy of Stabilization Splint and Low Level Laser Therapy for Treatment of Patients With Chronic Closed Lock of the Non-reducible Temporo-mandibular Joint Disc. A Parallel Randomized Clinical Trial.

Conditions
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TMJ Disc Disorder

Intervention / Treatment
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* Device: stabilization splint
* Device: laser therapy
* Device: stabilization splint and laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronic closed lock patients Must not be able to open their mouth Exclusion Criteria: neurologic diseases TMJ pathologic lesions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stabilization splint<br>acrylic splint in the maxillary arch with flat surface | Device: stabilization splint<br>* upper acrylic splint rest on the maxillary teeth and had flat surface<br>* Other names: upper acrylic full arch splint;|
| Active Comparator: laser therapy<br>laser beam directed to the affected part cause activation of blood circulation | Device: laser therapy<br>* The laser apparatus had a hand piece on which either a specially designed optic prism was attached to transfer laser energy to the tip of the prism<br>* Other names: Low-level laser therapy;|
| Active Comparator: stabilization splint and laser therapy<br>using both laser therapy and stabilization splint for more improvement | Device: stabilization splint and laser therapy<br>* the stabilization splint used in combination of treatment with laser therapy<br>* Other names: splint combined with low level laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of mouth opening | improvement in mouth opening or not | 6 months | 
| Masticatory muscles palpation | the masticatory muscles were palpated bilaterally with firm and constant pressure of one kg lasted two seconds to define painful areas | 6 months | 
| temporomandibular joint palpation | joint pain was achieved by first palpating the temporomandibular joint lateral pole by placing the index finger with firm and constant pressure of half kg lasted two seconds over the condyle in front of the tragus | 6 months |