Botulinum Toxin Versus Platelet Rich Fibrin for TMJ Internal Derangement

February 3, 2026 updated by: Suez Canal University

A Comparative Study Between Botulinum Toxin Versus Platelet Rich Fibrin Injection for Treatment of Temporomandibular Joint Internal Derangement

Temporomandibular joint (TMJ) internal derangement is a common cause of temporomandibular disorders and is often associated with pain, restricted mandibular movement, joint sounds, and functional limitations during mastication and mouth opening. Various treatment modalities have been proposed to manage these symptoms, aiming to reduce pain and improve joint function.

This randomized clinical study was conducted to compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) in the management of TMJ internal derangement. A total of 20 patients diagnosed with TMJ internal derangement were randomly allocated into two equal groups. Group I received intracapsular I-PRF injections into the superior joint space of the temporomandibular joint, while group II received botulinum toxin injections into the lateral pterygoid muscle.

Clinical evaluation was performed using subjective and objective parameters at one, three, and six months following treatment. Outcomes included assessment of pain, maximum mouth opening, mandibular movements, joint tenderness, and muscle tenderness upon palpation. Radiographic evaluation was conducted using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following the interventions.

The study aimed to determine which treatment modality provided superior clinical and radiographic outcomes for the management of TMJ internal derangement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Temporomandibular joint (TMJ) internal derangement represents a common cause of temporomandibular disorders (TMDs) and is frequently associated with pain and functional limitations. Patients affected by TMJ internal derangement commonly present with pain during mastication, difficulty or pain during mouth opening, joint sounds such as clicking or crepitation, and preauricular pain. Due to the multifactorial nature of this condition, numerous treatment modalities have been investigated to achieve effective symptom relief and functional improvement.

The aim of this clinical study was to evaluate and compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) for the management of TMJ internal derangement.

This randomized clinical study was conducted on a total of 20 patients diagnosed with TMJ internal derangement. The participants were randomly and equally allocated into two groups using an online randomization tool (www.randomizer.org). Group I consisted of 10 patients who received intracapsular injections of injectable platelet-rich fibrin (I-PRF) into the superior joint space of the temporomandibular joint. Group II consisted of 10 patients who received botulinum toxin type A injections into the lateral pterygoid muscle.

Patients in both groups were evaluated using both subjective and objective parameters at baseline and during follow-up periods at one month, three months, and six months following injection. Clinical evaluation included assessment of pain, maximum mouth opening, and mandibular movements in all directions to determine improvement in mouth mobility. Tenderness was assessed by palpation of the masticatory muscles, including the temporalis, masseter, and lateral pterygoid muscles, as well as palpation of the temporomandibular joint through the external auditory canal.

Radiographic evaluation was performed using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following treatment. MRI findings were used to evaluate joint structure, disc position, and overall intra-articular condition after the intervention.

The outcomes of this study were analyzed to determine which treatment modality provided superior clinical and radiographic improvement in patients with TMJ internal derangement.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Suez Canal University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • Patients willing to comply with the follow-up schedule and treatment protocol.

Exclusion Criteria:

  • Pregnant or lactating women, or women with osteoporosis.
  • 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.
  • Patients with previous trauma to the TMJ.
  • Patients with metal bullets in the body, metallic foreign body in the eye, or intracranial aneurysm clips (unless made of titanium).
  • Patients using anticoagulant or immunosuppressive medications.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I-PRF Injection Group (Group I)
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).
Procedure: Injectable Platelet-Rich Fibrin (I-PRF) Injection
Participants in this arm underwent arthrocentesis of the temporomandibular joint, followed by injection of 1 mL of intra-articular injectable platelet-rich fibrin (I-PRF) into the superior joint space.
Other Names:
  • I-PRF
  • Autologous Platelet-Rich Fibrin
Experimental: Botulinum Toxin Injection Group (Group II)
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.
Drug: Botulinum Toxin Type A (BOTOX) Injection
Participants in this arm received an ultrasound-guided injection of 7 mL containing 35 units of botulinum toxin type A (BOTOX) into the lateral pterygoid muscle.
Other Names:
  • BTX-A
  • Botulinum Neurotoxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score (Visual Analogue Scale, VAS)
Time Frame: 1 month, 3 months, and 6 months post-injection
Pain associated with temporomandibular joint internal derangement was assessed using a 10-point visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst pain. Pain was measured at baseline (pre-injection) and at follow-up visits. Comparisons were made within each group over time and between the I-PRF and BOTOX groups to determine the relative effectiveness of each treatment in reducing TMJ pain.
1 month, 3 months, and 6 months post-injection
Joint Sounds (Clicking) Assessment
Time Frame: 1 month, 3 months, and 6 months post-injection
The presence or absence of TMJ clicking was assessed by bimanual palpation during mouth opening and closing. Changes over time were recorded within groups and between the I-PRF and BOTOX groups.
1 month, 3 months, and 6 months post-injection
MRI Assessment of Disc Position
Time Frame: Baseline, 1 month, 3 months, and 6 months post-injection
MRI was performed to evaluate the position and structure of the TMJ articular disc. Disc positions were categorized as Superior (Normal), Reducing Disc Displacement (RDD), or Non-Reducing Disc Displacement (NRDD). Changes were compared within each group over time and between groups.
Baseline, 1 month, 3 months, and 6 months post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Mouth Opening (MMO)
Time Frame: 1 month, 3 months, and 6 months post-injection
MMO was measured from the incisal edge of the upper central incisors to the incisal edge of the lower central incisors using a digital caliper. Measurements were taken at baseline and follow-up visits. Changes were compared within and between the I-PRF and BOTOX groups to evaluate improvement in mouth opening.
1 month, 3 months, and 6 months post-injection
Lateral Mandibular Movements (Right and Left)
Time Frame: 1 month, 3 months, and 6 months post-injection
Right and left lateral mandibular movements were measured from the maxillary midline using a millimeter ruler or caliper. Changes in lateral movement were evaluated within each group over time and between groups.
1 month, 3 months, and 6 months post-injection
Protrusive Mandibular Movement (PM)
Time Frame: 1 month, 3 months, and 6 months post-injection
Protrusive mandibular movement was measured from the midpoint of the maxillary central incisors to the midpoint of the mandibular central incisors using a millimeter ruler or caliper. Progression was assessed within each group and between the I-PRF and BOTOX groups.
1 month, 3 months, and 6 months post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Study Chair: Mohamed Said Hamed, Professor, Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University
  • Study Director: Ahmed Abd elmohsen Younis, Assistant. Professor, Assistant. Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Actual)

March 11, 2025

Study Completion (Actual)

April 19, 2025

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 715/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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