Botulinum Toxin Versus Platelet Rich Fibrin for TMJ Internal Derangement

NCT07385742 | Completed

• 1 other identifier: 715/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Temporomandibular Joint; TMJ Internal Derangement; Botulinum Toxin Type A; BOTOX Injection; Platelet Rich Fibrin; Injectable PRF; Lateral Pterygoid Muscle

Outcome Measures

Primary Outcomes (3)

• Pain Score (Visual Analogue Scale, VAS)

  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

  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

  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 Outcomes (3)

• Maximal Mouth Opening (MMO)

  1 month, 3 months, and 6 months post-injection

• Lateral Mandibular Movements (Right and Left)

  1 month, 3 months, and 6 months post-injection

• Protrusive Mandibular Movement (PM)

  1 month, 3 months, and 6 months post-injection

Study Arms (2)

I-PRF Injection Group (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).

Procedure: Injectable Platelet-Rich Fibrin (I-PRF) Injection

Botulinum Toxin Injection Group (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.

Drug: Botulinum Toxin Type A (BOTOX) Injection

Interventions

Botulinum Toxin Type A (BOTOX) Injection DRUG

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.

Also known as: BTX-A, Botulinum Neurotoxin Type A

Botulinum Toxin Injection Group (Group II)

Injectable Platelet-Rich Fibrin (I-PRF) Injection PROCEDURE

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.

Also known as: I-PRF, Autologous Platelet-Rich Fibrin

I-PRF Injection Group (Group I)

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Location

Related Publications (7)

• Yoshida K. Botulinum Neurotoxin Injection for the Treatment of Recurrent Temporomandibular Joint Dislocation with and without Neurogenic Muscular Hyperactivity. Toxins (Basel). 2018 Apr 25;10(5):174. doi: 10.3390/toxins10050174.

  PMID: 29693593 BACKGROUND

• Rezazadeh F, Esnaashari N, Azad A, Emad S. The effects of botulinum toxin A injection on the lateral pterygoid muscle in patients with a painful temporomandibular joint click: a randomized clinical trial study. BMC Oral Health. 2022 May 31;22(1):217. doi: 10.1186/s12903-022-02220-3.

  PMID: 35641993 BACKGROUND

• Manafikhi M, Ataya J, Heshmeh O. Evaluation of the efficacy of platelet rich fibrin (I-PRF) intra-articular injections in the management of internal derangements of temporomandibular joints - a controlled preliminary prospective clinical study. BMC Musculoskelet Disord. 2022 May 14;23(1):454. doi: 10.1186/s12891-022-05421-7.

  PMID: 35568935 BACKGROUND

• Chung PY, Lin MT, Chang HP. Effectiveness of platelet-rich plasma injection in patients with temporomandibular joint osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019 Feb;127(2):106-116. doi: 10.1016/j.oooo.2018.09.003. Epub 2018 Sep 26.

  PMID: 30449691 BACKGROUND

• Bousnaki M, Bakopoulou A, Koidis P. Platelet-rich plasma for the therapeutic management of temporomandibular joint disorders: a systematic review. Int J Oral Maxillofac Surg. 2018 Feb;47(2):188-198. doi: 10.1016/j.ijom.2017.09.014. Epub 2017 Oct 20.

  PMID: 29066000 BACKGROUND

• Bakke M, Moller E, Werdelin LM, Dalager T, Kitai N, Kreiborg S. Treatment of severe temporomandibular joint clicking with botulinum toxin in the lateral pterygoid muscle in two cases of anterior disc displacement. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Dec;100(6):693-700. doi: 10.1016/j.tripleo.2004.11.019.

  PMID: 16301150 BACKGROUND

• Albilia J DMD, MSc, Herrera-Vizcaino C DDS, Weisleder H BSc, Choukroun J MD, Ghanaati S MD, DMD, PhD. Liquid platelet-rich fibrin injections as a treatment adjunct for painful temporomandibular joints: preliminary results. Cranio. 2020 Sep;38(5):292-304. doi: 10.1080/08869634.2018.1516183. Epub 2018 Sep 20.

  PMID: 30231809 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

proliferation regulatory factors, human urine; Injections; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Mohamed Said Hamed, Professor

  Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

  STUDY CHAIR

• Ahmed Abd elmohsen Younis, Assistant. Professor

  Assistant. Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study used a parallel assignment design in which 20 patients with temporomandibular joint internal derangement were randomly assigned into two equal groups. Group I received intracapsular injectable platelet-rich fibrin (I-PRF) into the superior joint space of the temporomandibular joint, while group II received botulinum toxin type A injections into the lateral pterygoid muscle. Each participant received only one of the two interventions and was followed for clinical and radiographic outcomes at one, three, and six months. The interventions were administered concurrently across groups, and the effects of each treatment were compared between the groups.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 4, 2026
• Study Start: January 10, 2024
• Primary Completion: March 11, 2025
• Study Completion: April 19, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)