Comparative Efficacy of Platelet Rich Plasma and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2021
CompletedStudy Start
First participant enrolled
September 4, 2021
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2023
CompletedSeptember 8, 2022
September 1, 2022
1.4 years
August 14, 2021
September 3, 2022
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (16)
Joint sounds
2 weeks
Joint sounds
4 weeks
Joint sounds
3 months
Joint sounds
6 months
Pain medication
2 weeks
- +11 more secondary outcomes
Study Arms (2)
Control group
ACTIVE COMPARATORPatients diagnosed with ADD under this group are subjected to Dry Needling
Test group
EXPERIMENTALPatients diagnosed with ADD under this group are administered with 1ml of PRP solution .
Interventions
Dry Needling will be done for the patients with ADD of TMJ in the retrodiscal tissue and superior joint space .
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.
Eligibility Criteria
You may qualify if:
- \- 1. Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
- \. Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PGIDS
Rohtak, Haryana, 124001, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2021
First Posted
September 8, 2022
Study Start
September 4, 2021
Primary Completion
February 15, 2023
Study Completion
March 15, 2023
Last Updated
September 8, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share