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NCT Number: NCT07385742

Botulinum Toxin Versus Platelet Rich Fibrin for TMJ 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.

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Key information

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: I-PRF, Autologous Platelet-Rich Fibrin

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.

Other names: BTX-A, Botulinum Neurotoxin Type A

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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