Ozonized platelet-rich plasma and ozonized platelet-rich fibrin in temporomandibular osteoarthritis. Fase II

Evaluation of the efficacy and safety of platelet-rich plasma and ozonized fibrin in the treatment of patients with temporomandibular joint osteoarthritis - OPAL-2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000477

Enrollment

Registered

2026-05-12

Start date

2026-05-15

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Temporomandibular joint osteoarthritis

Interventions

Group I (Experimental): Infiltration of ozonized platelet-rich plasma (PRP-O3), 3 sessions at 15-day intervals. Group II (Experimental): Infiltration of ozonized platelet-rich fibrin (PRF-O3), 3 sessi

Injections, Intra-Articular

Anesthesia, Local

Platelet-Rich Fibrin

Platelet-Rich Plasma

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1- Patients aged between 18 and 70 years 2- Patients with clinical and imaging diagnosis of bilateral temporomandibular joint osteoarthritis (TMJ OA) 3- Patients who did not respond to conservative treatment within 30 days 4- Analytical studies (complete blood count and blood chemistry) within normal parameters 5- Patients with complete dentition or rehabilitated with dental prostheses

Exclusion criteria

Exclusion criteria: 1- Patients with hematological or systemic diseases that contraindicate the use of platelet concentrates 2- Patients treated with anticoagulants 3- History of psychiatric disorders, infectious diseases, and malignant neoplasms 4- History of traumatic or surgical procedures in the temporomandibular joint 5- Pregnancy

Design outcomes

Primary

Measure	Time frame
1. Pain (Visual Analog Scale, 0–10). Measurement time: At baseline, 1 month, 3 months, and 6 months post-intervention. 2. Maximum mouth opening (millimeters, measured with caliper/ruler). Measurement time: At baseline, 1 month, 3 months, and 6 months post-intervention. 3. Joint crepitation (presence/absence, clinical examination). Measurement time: At baseline, 1 month, 3 months, and 6 months post-intervention. 4. Adverse effects and adverse reactions (presence/absence, patient report and clinical observation). Measurement time: Continuous monitoring during treatment and, at each follow-up visit (1, 3, and 6 months).	—

Measure

Time frame

1. Pain (Visual Analog Scale, 0–10). Measurement time: At baseline, 1 month, 3 months, and 6 months post-intervention. 2. Maximum mouth opening (millimeters, measured with caliper/ruler). Measurement time: At baseline, 1 month, 3 months, and 6 months post-intervention. 3. Joint crepitation (presence/absence, clinical examination). Measurement time: At baseline, 1 month, 3 months, and 6 months post-intervention. 4. Adverse effects and adverse reactions (presence/absence, patient report and clinical observation). Measurement time: Continuous monitoring during treatment and, at each follow-up visit (1, 3, and 6 months).

—

Secondary

Measure	Time frame
1. Total number of infiltrations (count of procedures performed per patient). Measurement time: Day 1 of treatment, at 2 weeks, and at 1 month. 2. Need for additional interventions (present/absent, clinical record of further procedures required). Measurement time: At a month, and 3 and 6 months 3. Days of work incapacity (number of days reported by the patient as unable to perform usual activities). Measurement time: At a month, and 3 and 6 months 4. Use of additional analgesic medication (present/absent, based on patient report and medical record review). Measurement time: At a month, and 3 and 6 months. 5. Patient satisfaction (5-point Likert scale, where 1 = Very dissatisfied and 5 = Very satisfied). Measurement time: 6 months after completion of the intervention.	—

Measure

Time frame

1. Total number of infiltrations (count of procedures performed per patient). Measurement time: Day 1 of treatment, at 2 weeks, and at 1 month. 2. Need for additional interventions (present/absent, clinical record of further procedures required). Measurement time: At a month, and 3 and 6 months 3. Days of work incapacity (number of days reported by the patient as unable to perform usual activities). Measurement time: At a month, and 3 and 6 months 4. Use of additional analgesic medication (present/absent, based on patient report and medical record review). Measurement time: At a month, and 3 and 6 months. 5. Patient satisfaction (5-point Likert scale, where 1 = Very dissatisfied and 5 = Very satisfied). Measurement time: 6 months after completion of the intervention.

—

Countries

Cuba

Contacts

Public ContactReynier Ramirez Suarez

Manuel Ascunce Domenech University Hospital

dirmad.cmw@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Jun 29, 2026