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

NCT07452289 | Completed

• 1 other identifier: 0932-06/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TMJ Disc Disorder

Outcome Measures

Primary Outcomes (2)

• Change in maximum mouth opening

  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.

  up to 6 months

• change in level of IL-6

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

  up to 6 months

Secondary Outcomes (2)

• change in lateral mandibular movement

  up to 6 months

• change in protrusive movement

  up to 6 months

Study Arms (2)

Study ozonated group

EXPERIMENTAL

Other: Ozonated water and PRP injection

Control group

ACTIVE COMPARATOR

Other: Ozonated water

Interventions

Ozonated water and PRP injection OTHER

patients will undergo arthrocentesis using ozonated water alongside PRP injection

Study ozonated group

Ozonated water OTHER

patients will undergo arthrocentesis using ozonated water alone.

Control group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

Study Design

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

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start: July 2, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

EG (1)