Clinical Trial

Botulinum Toxin Versus Platelet Rich Fibrin for TMJ Internal Derangement

Completed
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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.
Trial Details
NCT Number NCT07385742
Lead Sponsor Suez Canal University
Conditions Temporomandibular Joint Internal Derangement, Temporomandibular Joint Disorders, Temporomandibular Disorders (TMD), TMJ Pain
Enrollment 20 participants
Start Date 2024-01-10
Primary Completion 2025-03-11 (estimated)
Study Completion 2025-04-19 (estimated)
Updated on ClinicalTrials.gov 2026-02-04