Completed

Botulinum Toxin vs Platelet Rich Fibrin Injection for Temporomandibular Joint Internal Derangement Treatment

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Study Aim

This study aims to compare the effectiveness of Botulinum Toxin and Platelet Rich Fibrin injections in treating Temporomandibular Joint Internal Derangement, focusing on reducing joint sounds (clicking), improving disc position as seen on MRI, and decreasing pain levels.

What is being tested

Injectable Platelet-Rich Fibrin (I-PRF) Injection

+ Botulinum Toxin Type A (BOTOX) Injection

ProcedureDrug
Who is being recruted

Jaw Diseases+5

+ Joint Diseases

+ Mandibular Diseases

From 15 to 50 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorSuez Canal University
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 10, 2024

Actual date on which the first participant was enrolled.

This study focuses on a common condition called Temporomandibular Joint (TMJ) internal derangement, which often causes pain and difficulty in moving the jaw. People with this condition may experience pain while chewing, struggle with opening their mouth, hear clicking or crackling sounds in their jaw, and feel pain around their ear. The study aims to compare two different treatments: Botulinum Toxin Type A (BOTOX) and injectable platelet-rich fibrin (I-PRF). The goal is to see which treatment works better in reducing symptoms and improving jaw function for those with TMJ internal derangement. In this study, 20 patients with TMJ internal derangement are randomly divided into two groups. One group receives I-PRF injections directly into the affected jaw joint, while the other group gets BOTOX injections into a specific jaw muscle. Over a period of six months, patients are evaluated at different intervals. Check-ups include assessing pain levels, measuring how wide the mouth can open, examining jaw movements, and checking for tenderness in the jaw muscles and joint. Magnetic Resonance Imaging (MRI) is also used to observe changes in the joint structure and disc position after treatment. The study's results will help determine which treatment, I-PRF or BOTOX, provides better improvement in symptoms and joint condition.

Official TitleA Comparative Study Between Botulinum Toxin Versus Platelet Rich Fibrin Injection for Treatment of Temporomandibular Joint Internal Derangement
Principal SponsorSuez Canal University
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Jaw DiseasesJoint DiseasesMandibular DiseasesStomatognathic DiseasesMuscular DiseasesMusculoskeletal DiseasesTemporomandibular Joint DisordersCraniomandibular Disorders

Criteria

5 inclusion criteria required to participate
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).

Show More Criteria

8 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This arm included 10 patients who underwent arthrocentesis of the temporomandibular joint, followed by 1 mL of intra-articular injectable platelet-rich fibrin (I-PRF).

Group II

Experimental
This arm included 10 patients who received an ultrasound-guided injection of 7 mL containing 35 units of botulinum toxin type A (BOTOX) into the lateral pterygoid muscle.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Suez Canal University, Faculty of Dentistry

Ismailia, EgyptOpen Suez Canal University, Faculty of Dentistry in Google Maps
CompletedOne Study Center