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

Phase 2Active Not RecruitingNCT07798258

Cairo University24 enrolled

Overview

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.

Anterior disc displacement with reduction is a common intra-articular disorder of the temporomandibular joint and may be associated with clicking sounds, pain, and impaired mandibular function. This randomized clinical trial will compare injectable platelet-rich fibrin (I-PRF) with 25% dextrose injection in retrocondylar tissues in patients with anterior disc displacement with reduction. Participants will be randomly allocated into two parallel groups with an allocation ratio of 1:1. The intervention group will receive 1.5 cc of I-PRF injected into the retrocondylar tissues at 0, 2, and 4 weeks. The control group will receive 1.5 mL of 25% dextrose solution injected into the retrocondylar tissues at 0, 2, and 4 weeks. Clinical outcomes will include pain intensity assessed using a Visual Analogue Scale, maximum mouth opening measured using a digital caliper, and the presence or absence of clicking sounds. Magnetic resonance imaging will be performed before treatment and at 6 months after treatment to evaluate the position of the articular disc in open- and closed-mouth positions. Clinical assessments will be performed preoperatively and at 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

TMD

Interventions

PRF treatment groupDRUG

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 Approximately 10 mL of blood will be withdrawn from the patient's antecubital fossa using vacuum tubes and centrifuged at 700 RPM for 3 minutes for I-PRF preparation.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

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Pain Intensity

Pain intensity will be assessed using a Visual Analogue Scale (VAS), with 0 representing no or absent pain and 10 representing the worst or unbearable pain.

Time frame: 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)

Maximum mouth opening will be measured in millimeters from the incisal edge of the upper right central incisor to the lower right central incisor in the maximum mouth-open position using a digital caliper.

Temporomandibular Joint Clicking

The presence or absence of clicking sounds of the temporomandibular joint will be recorded.

Data from ClinicalTrials.gov

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