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

NCT ID: NCT05532098

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-04
• Study Completion Date: 2023-03-15

Brief Summary

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

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.

Conditions

Temporomandibular Joint Disc Displacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Patients diagnosed with ADD under this group are subjected to Dry Needling

Group Type: ACTIVE_COMPARATOR

Dry Needling

Intervention Type: PROCEDURE

Dry Needling will be done for the patients with ADD of TMJ in the retrodiscal tissue and superior joint space .

Test group

Patients diagnosed with ADD under this group are administered with 1ml of PRP solution .

Group Type: EXPERIMENTAL

PRP

Intervention Type: PROCEDURE

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.

Interventions

Dry Needling

Dry Needling will be done for the patients with ADD of TMJ in the retrodiscal tissue and superior joint space .

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PGIDS

Rohtak, Haryana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr.Ambika Gupta, MDS

Role: CONTACT

drambika79@rediffmail.com

9315903300

Facility Contacts

Dr.Sanjay Tiwari, MDS

Role: primary

principalpgids@yahoo.in

Other Identifiers

SURIYA N OMR

Identifier Type: -

Identifier Source: org_study_id