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Completed

NCT Number: NCT06207955

I-PRF After Arthrocentesis Plus Botox Injection to Lateral Pterygoid Muscle in Treatment of Anterior Disc Displacement

Aim of Study : To evaluate the efficacy of TMJ arhtrocentesis followed by injection of liquid platelet rich fibrin (I-PRF ) in addition to intramuscular injection of lateral pterygoid muscle with botulinum toxin on clinical outcomes of painful TMJ , maximum mouth opening , joint sounds and range of lateral movement in patients with TMJ anterior disc displacement with reduction

Hypothesis : Intramuscular injection of lateral pterygoid muscle with botulinum toxin plus TMJ intra-articular injection of liquid platelet rich fibrin after arthrocentesis are more effective than TMJ arthrocentesis followed by intra-articular injection of ( I-PRF ) or TMJ arthrocentesis only .

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Key information

Conditions

TMJ Disc Disorder TMJ Pain

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Fayoum University

Al Fayyum, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with painful tmj during jaw movements
  • Patients with joint sounds ( clicking ) during jaw opening and mastication
  • Patients age range from 16 years old to 45 years old
  • Patients with Class I maxillo-mandibular relationship
  • Patients with reduced mouth opening
  • All patients diagnosed clinically and radiographically by MRI as TMJ anterior disc displacement with reduction

Exclusion criteria

  • Patient with history of recent trauma
  • Patients with malocclusion
  • Patients with systematic condition that affect bone and joints such as osteoarthritis , systemic lupus and epilepsy .
  • Patients allergic to botox injection
  • Pregnant or lactating females
  • Patients with non-reducible disc on MRI
  • Patients contraindicated to exposure to MRI
  • Patients with previous tmj arthrocentesis , arthroscopy or TMJ surgery
  • Significant mechanical obstruction that prevents mouth opening, acute capsulitis, benign or malignant temporomandibular joint lesions.
  • Patients with blood diseases, and coagulation disorders

Treatment and study plan

TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A

Drug

TMJ Arthrocentesis I-PRF Intra-articular Injection Botulinum Toxin Type A to Lateral Pterygoid Muscle

TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin

Drug

TMJ Arthrocentesis I-PRF Intra-articular Injection

TMJ Arthrocentesis

Drug

TMJ Arthrocentesis By Saline

Primary outcomes

  1. Maximum Mouth Opening

    Time frame: 6 months

    Maximum mouth opening will be measured as the distance from incisal edges of the upper and lower central incisors using a ruler and will be evaluated preoperatively , immediately after the procedure , 1month , 3 months and 6 months postoperative .

Secondary outcomes

  1. Clicking

    Time frame: 6 months

    Joint sounds also will be evaluated during opening and closing of the jaws and during lateral movements preoperatively , immediately after the procedure , 1 months , 3 months and 6 months postoperative

  2. Lateral movement

    Time frame: 6 months

    Range of lateral mandibular movement will be measured using Vernier caliper in millimeters as the horizontal distance extending from maxillary midline to mandibular midline by asking the patient to move the mandible to one side then to the other side to maximum extent

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

Does Intra-articular Injection of Platelet-Rich Fibrin After Arthrocentesis Followed by Lateral Pterygoid Muscle Injection With Botulinum Toxin Type A Improve Clinical Outcomes for Anterior Disc Displacement?

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2024
Registry last updated
Sep 1, 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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