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

Evaluation of Hyaluronic Acid and I-PRF Mixture for Intra-articular Injection Following Arthrocentesis in The Management of TMJ Reducible Disc Displacement: A Four Arm Comparative Trial

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.

Study Overview

• Status: Recruiting
• Conditions: TMJ Disc Displacement With Reduction
• Intervention / Treatment: Procedure: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution; Procedure: Arthrocentesis followed by hyaluronic acid injection; Procedure: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture; Procedure: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture

Detailed Description

The purpose of this four-arm comparative clinical trial is to evaluate the efficacy of a combined intra-articular injection of Hyaluronic Acid (HA) and Injectable Platelet-Rich Fibrin (i-PRF) following arthrocentesi in patients suffering from temporomandibular joint (TMJ) reducible disc displacement.

All eligible participants will undergo standard TMJ arthrocentesis using Ringer's lactate solution to flush out inflammatory mediators and disrupt intra-articular adhesions.

Patients will be randomly assigned to one of four treatment protocols to compare therapeutic outcomes:

Group I: Arthrocentesis alone (Control). Group II: Arthrocentesis followed by intra-articular injection of Hyaluronic Acid only.

Group III: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and Betamethasone mixture.

Group IV: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and I-PRF mixture (Experimental).

Clinical outcomes include changes in maximum pain-free mouth opening, lateral/protrusive jaw movements, subjective pain intensity scores and presence or absence of clicking Clinical outcomes will be monitored and evaluated over a 6-month post-operative follow-up period to assess which intervention provides the most effective relief and functional restoration.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada Hamed; Phone Number: 00201119659235; Email: hamednada99@mans.edu.eg

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • Recruiting
    • Faculty of Dentistry Mansoura University
    • Contact: Faculty of Dentistry Mansoura University; Phone Number: 0020502267151; Email: dentfac@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: Arthrocentesis only	Procedure: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution; 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
Active Comparator: Group II: Arthrocentesis followed by hyaluronic acid injection	Procedure: Arthrocentesis followed by hyaluronic acid injection; 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of 1 ml of hyaluronic acid
Active Comparator: Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture	Procedure: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture; 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and betamethasone mixture
Active Comparator: Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture	Procedure: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture; 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and I-PRF mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clicking	clicking will be evaluated as either present or absent throughout the follow up intervals	preoperative, one week, one month, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Nada Hamed, Faculty of Dentistry Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: TMJ, Disc Displacement, Arthrocentesis, Hyaluronic Acid, I-PRF
• Other Study ID Numbers: MS.25.12.93

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No