I-PRF After Arthrocentesis Plus Botox Injection to Lateral Pterygoid Muscle in Treatment of Anterior Disc Displacement

Fayoum University

Status: Not yet enrolling

Conditions: TMJ Disc Disorder; TMJ Pain

Treatments: Drug: TMJ Arthrocentesis; Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin; Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT06207955

23122023

Details and patient eligibility

About

Aim of Study : To evaluate the efficacy of TMJ arhtrocentesis followed by injection of liquid platelet rich fibrin (I-PRF ) in addition to intramuscular injection of lateral pterygoid muscle with botulinum toxin on clinical outcomes of painful TMJ , maximum mouth opening , joint sounds and range of lateral movement in patients with TMJ anterior disc displacement with reduction

Hypothesis : Intramuscular injection of lateral pterygoid muscle with botulinum toxin plus TMJ intra-articular injection of liquid platelet rich fibrin after arthrocentesis are more effective than TMJ arthrocentesis followed by intra-articular injection of ( I-PRF ) or TMJ arthrocentesis only .

Enrollment: 39 estimated patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with painful tmj during jaw movements
• Patients with joint sounds ( clicking ) during jaw opening and mastication
• Patients age range from 16 years old to 45 years old
• Patients with Class I maxillo-mandibular relationship
• Patients with reduced mouth opening
• All patients diagnosed clinically and radiographically by MRI as TMJ anterior disc displacement with reduction

Exclusion criteria

• Patient with history of recent trauma
• Patients with malocclusion
• Patients with systematic condition that affect bone and joints such as osteoarthritis , systemic lupus and epilepsy .
• Patients allergic to botox injection
• Pregnant or lactating females
• Patients with non-reducible disc on MRI
• Patients contraindicated to exposure to MRI
• Patients with previous tmj arthrocentesis , arthroscopy or TMJ surgery
• Significant mechanical obstruction that prevents mouth opening, acute capsulitis, benign or malignant temporomandibular joint lesions.
• Patients with blood diseases, and coagulation disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle

Active Comparator group

Treatment:

Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A

TMJ arthrocentesis followed by intra-articular injection of liquid platelet rich fibrin ( I-PRF )

Active Comparator group

Treatment:

Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin

TMJ arthrocentesis

Active Comparator group

Treatment:

Drug: TMJ Arthrocentesis