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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

OPAL-2

Scientific title:

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

Acronym of Scientific Title:

OPAL-2

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center for Research and Biological Products (CENIPB)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Reynier

Last name:

Ramirez Suarez

Medical Specialty :

First and Second Degree Specialist in Maxillofacial Surgery

Affiliation:

Manuel Ascunce Domenech University Hospital

Postal address:

Carretera Central Oeste no. 305 entre Ave. Hospital y Calle 9 Rpto. Sanchez Soto

City:

Camaguey

País:

Cuba

Zip Code:

70100

Telephone:

+53-32298479

Email address:

dirmad.cmw@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/05/2026

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Temporomandibular joint osteoarthritis

Health condition(s) code:

Osteoarthritis

Temporomandibular Joint Disorders

Arthritis

Join Diseases

Rheumatic Diseases

Musculoskeletal diseases

Intervention(s):

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 sessions at 15-day intervals. Group III (Control): Infiltration of platelet-rich plasma (PRP), 3 sessions at 15-day intervals. Group IV (Control): Infiltration of platelet-rich fibrin (PRF), 3 sessions at 15-day intervals. Group V (Control): Conservative treatment (protocol-based management with analgesics and muscle relaxants). Paracetamol 500mg, Naproxen 400mg and, Baclofen 10mg, all of them by oral route every 8 hours during 2 weeks.

Intervention code:

Platelet-Rich Plasma

Platelet-Rich Fibrin

Anesthesia, Local

Injections, Intra-Articular

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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).

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

70 years

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:

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

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Reynier

Last Name:

Ramirez Suarez

Specialty:

First and Second Degree Specialist in Maxillofacial Surgery

Affiliation:

Manuel Ascunce Domenech University Hospital

Postal Address:

Carretera Central Oeste no. 305 entre Ave. Hospital y Calle 9 Rpto. Sanchez Soto

City:

Camaguey

País:

Cuba

Zip Code:

70100

Telephone:

+53-32291902

Email :

dirmad.cmw@infomed.sld.cu [1]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Reynier

Last Name:

Ramirez Suarez

Specialty:

First and Second Degree Specialist in Maxillofacial Surgery

Affiliation:

Manuel Ascunce Domenech University Hospital

Postal Address:

Carretera Central Oeste no. 305 entre Ave. Hospital y Calle 9 Rpto. Sanchez Soto

City:

Camaguey

País:

Cuba

Zip Code:

70100

Telephone:

+53-32291902

Email :

dirmad.cmw@infomed.sld.cu [1]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Manuel Ascunce Domenech University Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

10/02/2025

Postal address of Ethic Committee :

Carretera Central Oeste no. 305 entre Ave. Hospital y Calle 9 Rpto. Sanchez Soto, ZC: 70100, Camagüey, Cuba

Telephone:

+53-32248382

Correo electrónico:

gremb.cmw@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

28/03/2027

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000477

Date of Registration in Primary Registry:

12/05/2026

Record Verification Date:

2026/05/12

Next update date:

2027/05/12

Link to the spanish version:

Click here [2]