NCT05532098

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

September 4, 2021

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

August 14, 2021

Last Update Submit

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 COMPARATOR

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

Procedure: Dry Needling

Test group

EXPERIMENTAL

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

Procedure: PRP

Interventions

Dry NeedlingPROCEDURE

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

Control group
PRPPROCEDURE

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.

Test group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Dr.Ambika Gupta, MDS

CONTACT

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

Locations