Comparative Efficacy of Platelet Rich Plasma and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint

Study Overview
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Brief Summary
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Pain and trismus are of the prime concerns for the patients in case of Anterior disc displacement ADD of temporomandibular joint (TMJ). In the recent times, PRP has has produced promising results in management of TMDs. It has potential healing properties on new bone and cartilage through the recruitment, proliferation, migration, and differentiation of cells and its tissue remodelling, matrix production, and chondrogenic differentiation properties. It also increases the production of hyaluronic acid by synoviocytes. Needle injury also produces immediate analgesia without hypesthesia, mainly on the painful spot making it effective for the pain reduction and improved mouth opening. Similar effect of dry needling can also be expected in the joint space where it may induce a transient inflammatory cascade leading to healing of the damaged tissue. So, the Present study is designed to evaluate the efficacy of PRP for the treatment of ADD of TMJ.

Detailed Description
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Study Design: Randomized clinical trial Study Duration: This study will be completed in 1 year 3 months (3 months for patient recruitment, 9 months for study including treatment and follow up and 3 months for data compilation). Population: Patients suffering from Anterior Disc Displacement will be recruited in study from regular OPD of the Department of Oral Medicine and Radiology. Sample size: Sample size consists of 39 patients in each group. Methods: PRP will be performed in test group while dry needling will be performed in control group.

Official Title
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Comparative Efficacy of Platelet Rich Plasma and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint

Conditions
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Temporomandibular Joint Disc Displacement

Intervention / Treatment
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* Procedure: Dry Needling
* Procedure: PRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1. Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14). 2. Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging. Exclusion Criteria: 1. Patients with phobia to needles 2. Patients who have undergone previous treatment for anterior disc displacement in past 6 months 3. Patients with active infection at the site of injection 4. Patients on anticoagulant medication 5. Pregnancy/ Lactation 6. Patients with healing disorder or systemic disease where healing response is compromised 7. Patients with epilepsy/seizures 8. Patients with bleeding and clotting disorder 9. Patients with malignancy 10. Patients with uncontrolled para-functional habits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Patients diagnosed with ADD under this group are subjected to Dry Needling | Procedure: Dry Needling<br>* Dry Needling will be done for the patients with ADD of TMJ in the retrodiscal tissue and superior joint space .<br>|
| Experimental: Test group<br>Patients diagnosed with ADD under this group are administered with 1ml of PRP solution . | Procedure: PRP<br>* Patients with ADD are administered with 1ml of PRP into the retrodiscal tissue and the superior joint space. PRP will be prepared by method proposed by Okuda et al., 2003. Reinjection will be given after 2 weeks if required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score). | 2 weeks | 
| Pain intensity | To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score). | 4 weeks | 
| Pain intensity | To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score). | 3 months | 
| Pain intensity | To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score). | 6 months | 
| Mouth opening and Functional movements | To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre). | 2 weeks | 
| Mouth opening and Functional movements | To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre). | 4 weeks | 
| Mouth opening and Functional movements | To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre). | 3 months | 
| Mouth opening and Functional movements | To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint sounds | To evaluate the changes in joint sounds before and after the treatment (present or absent ). | 2 weeks | 
| Joint sounds | To evaluate the changes in joint sounds before and after the treatment (present or absent ). | 4 weeks | 
| Joint sounds | To evaluate the changes in joint sounds before and after the treatment (present or absent ). | 3 months | 
| Joint sounds | To evaluate the changes in joint sounds before and after the treatment (present or absent ). | 6 months | 
| Pain medication | To evaluate the need for pain medicine utilization (number of tablets). | 2 weeks | 
| Pain medication | To evaluate the need for pain medicine utilization (number of tablets). | 4 weeks | 
| Pain medication | To evaluate the need for pain medicine utilization (number of tablets). | 3 months | 
| Pain medication | To evaluate the need for pain medicine utilization (number of tablets). | 6 months | 
| Patient satisfaction | To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups | 2 weeks | 
| Patient satisfaction | To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups | 4 weeks | 
| Patient satisfaction | To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups | 3 months | 
| Patient satisfaction | To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups | 6 months | 
| Sleep pattern | To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups | 2 weeks | 
| Sleep pattern | To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups | 4 weeks | 
| Sleep pattern | To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups | 3 months | 
| Sleep pattern | To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups | 6 months |