Hyaluronic Acid and I-PRF Mixture for TMJ Disc Displacement Management

NCT07683650 | Recruiting DMC

• 1 other identifier: MS.25.12.93
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of hyaluronic acid and I-PRF mixture for intra-articular injection following arthrocentesis in the management of TMJ reducible disc displacement.

Conditions

TMJ Disc Displacement With Reduction

Keywords

TMJ; Disc Displacement With Reduction; Arthrocentesis; Hyaluronic Acid; I-PRF

Outcome Measures

Primary Outcomes (2)

• Intensity of pain

  Pain intensity will be evaluated subjectively using Numeric Rating Scale from zero to 10 zero indicates no pain at all 10 indicates the worst pain ever

  preoperative, one week, one month, 3 months and 6 months

• Maximum interincisal opening, lateral and protrusive movements

  1. Maximum interincisal opening: the distance in millimeters between the incisal edges of the central incisors in vertical direction at maximum pain free mouth opening, measured using a caliper. 2. Range of lateral and protrusive movements: the distance in millimeters between the upper and lower midlines in horizontal direction on lateral and protrusive movements, measured using a caliper.

  preoperative, one week, one month, 3 months and 6 months

Secondary Outcomes (1)

• Clicking

  preoperative, one week, one month, 3 months and 6 months

Study Arms (4)

Group I: Arthrocentesis only

ACTIVE COMPARATOR

Procedure: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution

Group II: Arthrocentesis followed by hyaluronic acid injection

ACTIVE COMPARATOR

Procedure: Arthrocentesis followed by hyaluronic acid injection

Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture

ACTIVE COMPARATOR

Procedure: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture

Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture

ACTIVE COMPARATOR

Procedure: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture

Interventions

18 joints that receive arthrocentesis using 100 ml of ringer lactate solution PROCEDURE

18 joints that receive arthrocentesis using 100 ml of ringer lactate solution

Group I: Arthrocentesis only

Arthrocentesis followed by hyaluronic acid injection PROCEDURE

18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of 1 ml of hyaluronic acid

Group II: Arthrocentesis followed by hyaluronic acid injection

Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture PROCEDURE

18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and betamethasone mixture

Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture

Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture PROCEDURE

18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and I-PRF mixture

Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 - 45 years.
• Patients with disc displacement with reduction in any of the TMJs.
• arthralgia.
• Limited unassisted mouth opening.
• Co-operative patients.

You may not qualify if:

• Patients with previous history of TMJ minimally invasive interventions.
• Patients with autoimmune or connective tissue diseases affecting the joints.
• Patients with neurological disorders.
• Patients with a history of condylar fractures or ankylosis.
• Patients with psychological problems.
• Patients receiving non-steroidal anti-inflammatory drugs within 48 hours preoperatively, or systemic use of corticosteroids within 2 weeks.
• Patients on anticoagulants, suffering from platelet function disorders or fibrinogen deficiency.
• Patients with moderate to severe myogenic pain.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry Mansoura University

Al Mansurah, Egypt

RECRUITING

Study Officials

• Nada Hamed

  Faculty of Dentistry Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada Hamed

CONTACT

00201119659235; hamednada99@mans.edu.eg

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: June 29, 2026
• First Posted: July 6, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)