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

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?

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: TMJ Disc Disorder; TMJ Pain
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed T Ahmed, Dentist; Phone Number: +20 1006325722; Email: at1219@fayoum.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle	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
Active Comparator: TMJ arthrocentesis followed by intra-articular injection of liquid platelet rich fibrin ( I-PRF )	Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin; TMJ Arthrocentesis I-PRF Intra-articular Injection
Active Comparator: TMJ arthrocentesis	Drug: TMJ Arthrocentesis; TMJ Arthrocentesis By Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 23, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Botulinum Toxin Type A; Arthrocentesis; I-PRF; Anterior Disc Displacement; TMJ Clicking; Lateral Pterygoid Muscle
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 23122023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No