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

TMJ Disc Disorder Clinical Trial

Official title:

Does Intra-articular Injection of Platelet-Rich Fibrin After Arthrocentesis Followed by Lateral Pterygoid Muscle Injection With Botulinum Toxin Type A Improve Clinical Outcomes for Anterior Disc Displacement?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06207955
• Other study ID #: 23122023
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Fayoum University
• Contact: Ahmed T Ahmed, Dentist
• Phone: 1006325722
• Email: at1219[@]fayoum.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• TMJ Disc Disorder
• TMJ Pain

Intervention

Drug:
• TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A
TMJ Arthrocentesis I-PRF Intra-articular Injection Botulinum Toxin Type A to Lateral Pterygoid Muscle
• TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin
TMJ Arthrocentesis I-PRF Intra-articular Injection
• TMJ Arthrocentesis
TMJ Arthrocentesis By Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Mouth Opening	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 .	6 months
Secondary	Clicking	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	6 months
Secondary	Lateral movement	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	6 months