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NCT Number: NCT07683650

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

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.

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Key information

Conditions

TMJ Disc Displacement With Reduction

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Mansoura University

Al Mansurah, Egypt

Location status: Recruiting

Location contact

Faculty of Dentistry Mansoura University

CONTACT

[email protected]

0020502267151

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

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

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

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

Primary outcomes

  1. Intensity of pain

    Time frame: preoperative, one week, one month, 3 months and 6 months

    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

  2. Maximum interincisal opening, lateral and protrusive movements

    Time frame: preoperative, one week, one month, 3 months and 6 months

    • 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.

Secondary outcomes

  1. Clicking

    Time frame: preoperative, one week, one month, 3 months and 6 months

    clicking will be evaluated as either present or absent throughout the follow up intervals

Study contacts

Contact information is provided by the study sponsor or research team.

Nada Hamed

CONTACT

[email protected]

00201119659235

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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