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

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)

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.

Study Overview

• Status: Completed
• Conditions: TMJ Disc Disorder
• Intervention / Treatment: Other: Ozonated water and PRP injection; Other: Ozonated water

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Ozonated water; patients will undergo arthrocentesis using ozonated water alone.
Experimental: Study ozonated group	Other: Ozonated water and PRP injection; patients will undergo arthrocentesis using ozonated water alongside PRP injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in lateral mandibular movement	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	up to 6 months
change in protrusive movement	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.	up to 6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 0932-06/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No