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COMPLETED
NCT07385742
NA

Arthrocentesis-PRF Versus Botulinum Toxin for Management of ADDwR

Sponsor: Suez Canal University

View on ClinicalTrials.gov

Summary

Temporomandibular joint (TMJ) internal derangement is a common cause of temporomandibular disorders and is often associated with pain, restricted mandibular movement, joint sounds, and functional limitations during mastication and mouth opening. Various treatment modalities have been proposed to manage these symptoms, aiming to reduce pain and improve joint function. This randomized clinical study was conducted to compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) in the management of TMJ internal derangement. A total of 20 patients diagnosed with TMJ internal derangement were randomly allocated into two equal groups. Group I received intracapsular I-PRF injections into the superior joint space of the temporomandibular joint, while group II received botulinum toxin injections into the lateral pterygoid muscle. Clinical evaluation was performed using subjective and objective parameters at one, three, and six months following treatment. Outcomes included assessment of pain, maximum mouth opening, mandibular movements, joint tenderness, and muscle tenderness upon palpation. Radiographic evaluation was conducted using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following the interventions. The study aimed to determine which treatment modality provided superior clinical and radiographic outcomes for the management of TMJ internal derangement.

Official title: A Comparative Study Between Arthrocentesis Combined With Intra-Articular Injectable Platelet-Rich Fibrin Versus Ultrasound-Guided Lateral Pterygoid Botulinum Toxin Injection For Management of Anterior Disc Displacement With Reduction

Key Details

Gender

All

Age Range

15 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-01-10

Completion Date

2025-04-19

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

PROCEDURE

Injectable Platelet-Rich Fibrin (I-PRF) Injection

Participants in this arm underwent arthrocentesis of the temporomandibular joint, followed by injection of 1 mL of intra-articular injectable platelet-rich fibrin (I-PRF) into the superior joint space.

DRUG

Botulinum Toxin Type A (BOTOX) Injection

Participants in this arm received an ultrasound-guided injection of 7 mL containing 35 units of botulinum toxin type A (BOTOX) into the lateral pterygoid muscle.

Locations (1)

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt