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Botulinum Toxin Versus Platelet Rich Fibrin for TMJ Internal Derangement

NCT07385742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-04

No results posted yet for this study

Summary

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.

Conditions

  • Temporomandibular Joint Internal Derangement
  • Temporomandibular Joint Disorders
  • Temporomandibular Disorders (TMD)
  • TMJ Pain

Interventions

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.

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.

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Mohamed Said Hamed, Professor · Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

  • Ahmed Abd elmohsen Younis, Assistant. Professor · Assistant. Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2025-03-11
Completion
2025-04-19

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07385742 on ClinicalTrials.gov