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

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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Joint Disc Displacement
• Intervention / Treatment: Procedure: Dry Needling; Procedure: PRP

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr.Ambika Gupta, MDS; Phone Number: 9315903300; Email: drambika79@rediffmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS
      • Contact: Dr.Sanjay Tiwari, MDS; Email: principalpgids@yahoo.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group; Patients diagnosed with ADD under this group are subjected to Dry Needling	Procedure: Dry Needling; Dry Needling will be done for the patients with ADD of TMJ in the retrodiscal tissue and superior joint space .
EXPERIMENTAL: Test group; Patients diagnosed with ADD under this group are administered with 1ml of PRP solution .	Procedure: PRP; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2021
• Primary Completion (ANTICIPATED): February 15, 2023
• Study Completion (ANTICIPATED): March 15, 2023

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: September 3, 2022
• First Posted (ACTUAL): September 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 3, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SURIYA N OMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No