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

Temporomandibular Joint Disc Displacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532098
• Other study ID #: SURIYA N OMR
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: September 2022
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Dr.Ambika Gupta, MDS
• Phone: 9315903300
• Email: drambika79[@]rediffmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: March 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Joint Disc Displacement

Intervention

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

Locations

Country	Name	City	State
India	PGIDS	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).	2 weeks
Primary	Pain intensity	To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).	4 weeks
Primary	Pain intensity	To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).	3 months
Primary	Pain intensity	To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).	6 months
Primary	Mouth opening and Functional movements	To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).	2 weeks
Primary	Mouth opening and Functional movements	To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).	4 weeks
Primary	Mouth opening and Functional movements	To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).	3 months
Primary	Mouth opening and Functional movements	To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).	6 months
Secondary	Joint sounds	To evaluate the changes in joint sounds before and after the treatment (present or absent ).	2 weeks
Secondary	Joint sounds	To evaluate the changes in joint sounds before and after the treatment (present or absent ).	4 weeks
Secondary	Joint sounds	To evaluate the changes in joint sounds before and after the treatment (present or absent ).	3 months
Secondary	Joint sounds	To evaluate the changes in joint sounds before and after the treatment (present or absent ).	6 months
Secondary	Pain medication	To evaluate the need for pain medicine utilization (number of tablets).	2 weeks
Secondary	Pain medication	To evaluate the need for pain medicine utilization (number of tablets).	4 weeks
Secondary	Pain medication	To evaluate the need for pain medicine utilization (number of tablets).	3 months
Secondary	Pain medication	To evaluate the need for pain medicine utilization (number of tablets).	6 months
Secondary	Patient satisfaction	To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups	2 weeks
Secondary	Patient satisfaction	To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups	4 weeks
Secondary	Patient satisfaction	To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups	3 months
Secondary	Patient satisfaction	To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups	6 months
Secondary	Sleep pattern	To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups	2 weeks
Secondary	Sleep pattern	To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups	4 weeks
Secondary	Sleep pattern	To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups	3 months
Secondary	Sleep pattern	To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups	6 months