Assessment of Injectable PRF Versus Dextrose Injection in Temporomandibular Joint in Anterior Disc Displacement With Reduction

NCT07798258 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Phase 2

Started

2025-10-10

Last updated

2026-09-01

Condition(s) studied

TMD

Investigational drug(s) / intervention(s)

PRF treatment groupDextrose 20% Prolotherapy →

PRF treatment group: Participants in the I-PRF group will receive 1.5 cc of injectable platelet-rich fibrin (I-PRF) injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. Approximately 10 mL of blood will be withdrawn from the patient's antecubital fossa using vacuum tubes and centrifuged at 700 RPM for 3 minutes for I-PRF preparation. The resulting I-PRF will be transferred using a sterile 22-gauge 3 mL plastic syringe and injected into the retrocondylar tissues. In cases of bilateral involvement, the procedure will be repeated on the opposite side.

Dextrose 20% Prolotherapy: Participants in the control group will receive 1.5 mL of 25% hypertonic dextrose solution injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. The solution will be mixed with 0.2 mL of local anaesthetic solution containing 2% mepivacaine hydrochloride with 1:20,000 levonordefrin. The substances will be injected under aseptic conditions using a 22-gauge needle. In cases of bilateral involvement, the procedure will be repeated on the opposite side.

Study summary

This randomized clinical trial aims to compare the accuracy and effectiveness of injectable platelet-rich fibrin (I-PRF) versus 25% dextrose prolotherapy injected into retrocondylar tissues in patients with anterior disc displacement with reduction of the temporomandibular joint. The study will evaluate improvement in disc position, pain, mouth opening, and clicking sounds following treatment.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participants must meet all of the following criteria: Age ≥18 years. Female patients. Patients with anterior disc displacement with reduction. Anterior disc displacement with reduction assessed using preoperative MRI in open- and closed-mouth positions. Patients who are willing and fully capable of complying with the study protocol. Exclusion Criteria: * Participants will be excluded if they have: Bleeding disorders or are receiving anticoagulant medications. Pregnancy. Bony pathology of the temporomandibular joint. Temporomandibular disorder patients or patients with anterior disc displacement without reduction. Any temporomandibular joint infection. Mental instabilities or psychiatric conditions. Previous invasive or surgical procedures of the temporomandibular joint. Inability to attend follow-up during the entire follow-up period. Refusal to sign the written informed consent. Dystonia.

Primary outcome measure(s)

Improvement in the Position of the Articular Disc — 6 months
Improvement in the position of the articular disc will be assessed by comparing preoperative and postoperative MRI measurements of disc position in both closed- and open-mouth positions.

Trial sites (1)

Facility	City	Region	Status
Faculty of Dentistry, Cairo University	Cairo	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07798258 on ClinicalTrials.gov ↗ ← All trials in Egypt