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Completed

NCT Number: NCT07452289

Arthrocentesis of Temporomandibular Joint Using Ozonated Water Alongside With Platelet Rich Plasma Injection in Management of Anterior Disc Displacement Without Reduction:

Background: The temporomandibular joint (TMJ) is a highly intricate and complex synovial joint found in the human body. When TMJ dysfunction occurs, it causes pain and difficulties in opening the mouth, significantly impacting the patient's quality of life. Internal derangements, characterized by the gradual displacement of the articular disc, stand out as the most prevalent intra-articular temporomandibular disorders. Temporomandibular joint arthrocentesis, a procedure utilizing different irrigating solutions, is acknowledged as an efficient therapy for managing internal derangements of the TMJ. Recently, ozone therapy and orthobiologics like Platelet rich plasma (PRP) have been attracting increasing attention worldwide due to their promising medical applications and diverse therapeutic benefits in management of joint dysfunctions.

Aim of this study: The aim of the study is to compare the effectiveness of temporomandibular joint arthrocentesis using ozonated water combined with platelet-rich plasma (PRP) injection versus ozonated water alone for treating Wilkes stages III and IV of anterior disc displacement in terms of pain score, maximum mouth opening, and range of motion. Additionally, the study aims to compare the impact of both treatments on the concentration of the proinflammatory cytokine interleukin-6 (IL-6) in the joint space.

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Key information

Conditions

TMJ Disc Disorder

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pain located in the affected TMJ, especially during opening.
  • Joint noises.
  • Limited mouth opening (less than 35 mm).
  • Impeded lateral movement toward the unaffected side.
  • Deflection toward the affected side in opening in cases of unilateral affection.
  • Patient who did not respond to conservative management.

Exclusion criteria

  • Patients receiving anticoagulation treatment or non-steroidal anti-inflammatory drugs within 48 hours preoperatively, corticosteroid injection at the treatment site within 1 month, or systemic use of corticosteroids within 2 weeks.
  • Patients suffering from any systemic inflammatory (degenerative) joint disease, and bleeding disorders such as coagulation disorders, platelet disorders, vascular disorders, and fibrinolytic defects.
  • Patients with overlying infection or cellulitis in preauricular region.
  • Patients with condylar pathology (hypoplasia, hyperplasia or tumor).
  • Patients with previous open TMJ surgery or previous joint fracture.
  • Patients with normal disc positions as seen by the MRI and the limitation is due to another extraarticular cause such as zygomatic arch fracture or elongated coronoid process.

Treatment and study plan

Ozonated water and PRP injection

Other

patients will undergo arthrocentesis using ozonated water alongside PRP injection

Ozonated water

Other

patients will undergo arthrocentesis using ozonated water alone.

Primary outcomes

  1. Change in maximum mouth opening

    Time frame: up to 6 months

    mouth opening will be measured as the maximal distance between the cutting edge of the maxillary and mandibular central incisors using a millimeter ruler in the superioinferior direction.

  2. change in level of IL-6

    Time frame: up to 6 months

    synovial fluid samples will be collected to detect the level of IL-6

Secondary outcomes

  1. change in lateral mandibular movement

    Time frame: up to 6 months

    The range of lateral mandibular movement will be measured after moving the mandible as far as possible to the right, and then to the left, starting from the mandibular rest position. Then, the distance between the lower and upper central incisor lines will be measured in the mediolateral direction

  2. change in protrusive movement

    Time frame: up to 6 months

    The range of protrusive movement will be measured after protruding the mandible as far as possible from the rest position. Then, the distance between the labial surface of the upper and lower incisors in the anteroposterior direction will be measured.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Arthrocentesis of Temporomandibular Joint Using Ozonated Water Alongside With Platelet Rich Plasma Injection in Management of Anterior Disc Displacement Without Reduction: (Randomized Controlled Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2026
Registry last updated
Mar 5, 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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