Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction

Study Overview
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Brief Summary
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Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.

Official Title
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Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction (A Randomized Clinical Trial)

Conditions
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Temporomandibular Joint Disc Displacement, With Reduction

Intervention / Treatment
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* Device: Low level laser therapy
* Drug: Botulinum toxin type A
* Device: Anterior repositioning appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TMJ with audible and palpable click. Patients with anterior disc displacement as detected by MRI. Presence of full or nearly full complement of natural teeth. Exclusion Criteria: Patients who have radiographic evidence of degenerative conditions of TMJ. Patients who have anterior disc dislocation without reduction. Previous history of TMD treatment. History of recent trauma. The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis). Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices. Pregnant and lactating females. Patients with known allergy to botulinum toxin type A. Patients suffering from neurological disorders.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low level laser therapy<br> | Device: Low level laser therapy<br>* Patients will receive low-level laser therapy on the temporomandibular joint disc<br>* Other names: LLLT;|
| Experimental: Botulinum toxin type A<br> | Drug: Botulinum toxin type A<br>* Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.<br>* Other names: Botox;|
| Active Comparator: Anterior repositioning appliance<br> | Device: Anterior repositioning appliance<br>* Patients will receive hard maxillary anterior repositioning appliance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporomandibular joint dysfunction | Using Helkimo Anamnestic Index that includes 5 items, each having 3 possible answers scored 0, 1 or 5. The 1st item assesses limitations in range of jaw movement & is divided to 4 sections: maximum mouth opening, protrusion & lateral shift. For mouth opening , value of >40mm scores 0, 30-39mm scores 1 & <30mm scores 5. Protrusion & lateral shifts score 0 if the measurement is ≥7mm, 1 if ranging between 4-6mm and 5 if it is <4mm. These sections are added together to get a total that scores 0 if the sum of the 4 sections is 0, 1 if the subtotal is between 1-4 & 5 if the subtotal is >4. The 2nd item evaluates joint alterations that produce deviations, sounds and joint locks. The 3rd item evaluates pain when performing movements. The 4th item evaluates masticatory muscles pain. The 5th item evaluates pain on palpation in the prearticular area of TMJ. The 5 items are added and scored; 0: no TMJ involvement, 1-9: mild involvement, 10-19: moderate involvement & 20-25: severe involvement | 3 months | 
| Pain level | This will be assessed using the visual analogue scale (VAS) with score ranges from 0 (lowest) to 10 (highest). Higher scores indicate greater pain levels. | 3 months | 
| Temporomandibular joint clinical evaluation | Magnetic Resonance Imaging (MRI) will be performed for all patients using a 3 Tesla MRI scanner with a head coil. Gradient T2 (T2*) and proton-density (PD) weighted spin echo (SE) sequences will be carried out in closed and open mouth positions in the oblique sagittal plane. MRI is considered the gold standard (objective) in imaging the soft tissue components of the TMJ. | 3 months |