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

NCT07798258 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: Oms3-3-3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TMD

Keywords

Disc Displacement with reduction; Dextrose in retrodiscal tissue; injectable PRF

Outcome Measures

Primary Outcomes (1)

• Improvement in the Position of the Articular Disc

  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.

  6 months

Secondary Outcomes (3)

• Pain Intensity

  Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.

• Maximum Mouth Opening (MMO)

  Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.

• Temporomandibular Joint Clicking

  Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.

Study Arms (2)

I-PRF Group

EXPERIMENTAL

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 Approximately 10 mL of blood will be withdrawn from the patient's antecubital fossa using vacuum tubes and centrifuged at 700 RPM for 3 minutes for I-PRF preparation.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.

Drug: PRF treatment group

Dextrose 25% Group

ACTIVE COMPARATOR

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.

Drug: Dextrose 20% Prolotherapy

Interventions

PRF treatment group DRUG

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.

I-PRF Group

Dextrose 20% Prolotherapy DRUG

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.

Dextrose 25% Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Glucose; Prolotherapy

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial Surgery resident

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): February 10, 2027
• Last Updated: September 1, 2026

Record last verified: 2025-10

Locations

EG (1)