CClinicalTrials.gg
Status unknownNCT05532098Updated Sep 8, 2022

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

An interventional study of Dry Needling and PRP in Temporomandibular Joint Disc Displacement, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Status unknown at 1 site in India. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.

Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Temporomandibular Joint Disc Displacement
03

In context

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
  1. Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Active comparator
    Control group

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

    Procedure: Dry Needling

  • Experimental
    Test group

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

    Procedure: PRP

Interventions

  • ProcedureDry Needling

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

  • ProcedurePRP

    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.

06

What researchers measure

Primary outcomes

  1. Pain intensity

    To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).

    Time frame: 2 weeks

  2. Pain intensity

    To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).

    Time frame: 4 weeks

  3. Pain intensity

    To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).

    Time frame: 3 months

  4. Pain intensity

    To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).

    Time frame: 6 months

  5. Mouth opening and Functional movements

    To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).

    Time frame: 2 weeks

  6. Mouth opening and Functional movements

    To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).

    Time frame: 4 weeks

  7. Mouth opening and Functional movements

    To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).

    Time frame: 3 months

  8. Mouth opening and Functional movements

    To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).

    Time frame: 6 months

Secondary outcomes

  1. Joint sounds

    To evaluate the changes in joint sounds before and after the treatment (present or absent ).

    Time frame: 2 weeks

  2. Joint sounds

    To evaluate the changes in joint sounds before and after the treatment (present or absent ).

    Time frame: 4 weeks

  3. Joint sounds

    To evaluate the changes in joint sounds before and after the treatment (present or absent ).

    Time frame: 3 months

  4. Joint sounds

    To evaluate the changes in joint sounds before and after the treatment (present or absent ).

    Time frame: 6 months

  5. Pain medication

    To evaluate the need for pain medicine utilization (number of tablets).

    Time frame: 2 weeks

  6. Pain medication

    To evaluate the need for pain medicine utilization (number of tablets).

    Time frame: 4 weeks

  7. Pain medication

    To evaluate the need for pain medicine utilization (number of tablets).

    Time frame: 3 months

  8. Pain medication

    To evaluate the need for pain medicine utilization (number of tablets).

    Time frame: 6 months

  9. Patient satisfaction

    To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups

    Time frame: 2 weeks

  10. Patient satisfaction

    To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups

    Time frame: 4 weeks

  11. Patient satisfaction

    To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups

    Time frame: 3 months

  12. Patient satisfaction

    To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups

    Time frame: 6 months

  13. Sleep pattern

    To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups

    Time frame: 2 weeks

  14. Sleep pattern

    To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups

    Time frame: 4 weeks

  15. Sleep pattern

    To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups

    Time frame: 3 months

  16. Sleep pattern

    To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05532098
Lead sponsor
Postgraduate Institute of Dental Sciences Rohtak
Responsible party
Sponsor
First posted
Sep 8, 2022
Start date
Sep 4, 2021
Primary completion
Feb 15, 2023 (estimated)
Completion
Mar 15, 2023 (estimated)
Last update
Sep 8, 2022

Study contacts

Dr.Ambika Gupta, MDS
Contact
drambika79@rediffmail.com
9315903300

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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