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Completed NCT07385742

Arthrocentesis-PRF Versus Botulinum Toxin for Management of ADDwR

Conditions: Temporomandibular Joint Internal Derangement, Temporomandibular Joint Disorders, Temporomandibular Disorders (TMD), TMJ Pain

Sex: All
Ages: 15 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Suez Canal University

Location: Suez Canal University, Faculty of Dentistry Ismailia

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.

Eligibility Criteria

Inclusion Criteria: * Patients aged 15 to 50 years. * Adults of both genders. * Patients free from systemic disease (ASA I). * Patients presenting with persistent symptoms and signs of temporomandibular disorders, specifically anterior disc displacement with reduction (ADDwR). * Patients willing to comply with the follow-up schedule and treatment protocol. Exclusion Criteria: * Pregnant or lactating women, or women with osteoporosis. * Patients who have had previous TMJ surgery. * Patients who have undergone previous arthrocentesis. * Any other temporomandibular joint disease that may confound diagnosis (e.g., myofascial pain-dysfunction syndrome, MPDS). * Patients allergic to components of the injection solutions. * Patients with previous trauma to the TMJ. * Patients with metal bullets in the body, metallic foreign body in the eye, or intracranial aneurysm clips (unless made of titanium). * Patients using anticoagulant or immunosuppressive medications.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07385742). StuddyBuddy aggregates publicly available trial information.