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

Not Applicable

Not yet recruiting

• Conditions: TMJ Disc Disorder; TMJ Pain
• Interventions: Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A; Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin; Drug: TMJ Arthrocentesis

• Registration Number: NCT06207955
• Lead Sponsor: Fayoum University

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-23
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-05
• Last Update Submitted: 2024-01-05
• Study First Posted: 2024-01-17
• Last Update Posted: 2024-01-17
• Study Start: 2024-02
• Primary Completion: 2024-12
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle	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 )	TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin	-
TMJ arthrocentesis	TMJ Arthrocentesis	-

Primary Outcome Measures

Name	Time	Method
Maximum Mouth Opening	6 months	Maximum mouth opening will be measured as the distance from incisal edges of the upper and lower central incisors using a ruler and will be evaluated preoperatively , immediately after the procedure , 1month , 3 months and 6 months postoperative .

Secondary Outcome Measures

Name	Time	Method
Lateral movement	6 months	Range of lateral mandibular movement will be measured using Vernier caliper in millimeters as the horizontal distance extending from maxillary midline to mandibular midline by asking the patient to move the mandible to one side then to the other side to maximum extent
Clicking	6 months	Joint sounds also will be evaluated during opening and closing of the jaws and during lateral movements preoperatively , immediately after the procedure , 1 months , 3 months and 6 months postoperative