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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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07452289
Enrollment
20
Registered
2026-03-05
Start date
2024-07-02
Completion date
2025-05-15
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMJ Disc Disorder

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.

Interventions

OTHEROzonated water and PRP injection

patients will undergo arthrocentesis using ozonated water alongside PRP injection

patients will undergo arthrocentesis using ozonated water alone.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in maximum mouth openingup to 6 monthsmouth 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.
change in level of IL-6up to 6 monthssynovial fluid samples will be collected to detect the level of IL-6

Secondary

MeasureTime frameDescription
change in lateral mandibular movementup to 6 monthsThe 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
change in protrusive movementup to 6 monthsThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026