Clinical trial NCT05532098: Comparative Efficacy of Platelet Rich Plasma and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint
Official title: Comparative Efficacy of Platelet Rich Plasma and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disc Displacement
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: 2 weeks
measure: Pain intensity
timeFrame: 4 weeks
measure: Pain intensity
timeFrame: 3 months
measure: Pain intensity
timeFrame: 6 months
measure: Mouth opening and Functional movements
timeFrame: 2 weeks
measure: Mouth opening and Functional movements
timeFrame: 4 weeks
measure: Mouth opening and Functional movements
timeFrame: 3 months
measure: Mouth opening and Functional movements
timeFrame: 6 months
Secondary outcomes:
measure: Joint sounds
timeFrame: 2 weeks
measure: Joint sounds
timeFrame: 4 weeks
measure: Joint sounds
timeFrame: 3 months
measure: Joint sounds
timeFrame: 6 months
measure: Pain medication
timeFrame: 2 weeks
measure: Pain medication
timeFrame: 4 weeks
measure: Pain medication
timeFrame: 3 months
measure: Pain medication
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 2 weeks
measure: Patient satisfaction
timeFrame: 4 weeks
measure: Patient satisfaction
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 6 months
measure: Sleep pattern
timeFrame: 2 weeks
measure: Sleep pattern
timeFrame: 4 weeks
measure: Sleep pattern
timeFrame: 3 months
measure: Sleep pattern
timeFrame: 6 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
References: