Efficacy of Platelet-rich Fibrin in the treatment of Temporomandibular Joint Osteoarthritis

Clinical study to evaluate Platelet-rich Fibrin in the control of Temporomandibular Osteoarthritis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-9rdw98s

Enrollment

Unknown

Registered

2025-07-11

Start date

2025-01-24

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Temporomandibular Joint Disorders

Interventions

This is a randomized, blinded clinical trial. A total of 45 individuals who meet the eligibility criteria will be probabilistically allocated to one or another intervention group using a random sequen

Experimental treatment 2) Combination of autologous platelet-rich fibrin and hyaluronic acid

active comparator 3) hyaluronic acid. Each treatment will be injected after arthrocentesis, a minimally invasive procedure performed under local anesthesia. Three therapeutic applications will be perf

D09.698.373.475

A12.207.152.693.600.500

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with Temporomandibular Joint (TMJ) osteoarthritis. Age above 18.

Exclusion criteria

Exclusion criteria: Patients in an advanced stage of osteoarthritis, with signs of generalized sclerosis in magnetic resonance image. Pregnant or breastfeeding patients (since the risks involved are not known). Patients with local infection. Patients with hereditary coagulopathies. Patients with rheumatological diseases. Patients under chronic use of corticosteroids and immunosuppressants.

Design outcomes

Secondary

Measure	Time frame
To compare the characteristic intensity of pain on the day of inclusion in the study (without treatment) with days 15, 30, 45, 60, 90 and 180 days, after the last injection of treatment, in participants submitted to the 3 arms of the study.;Compare the maximum pain-free mouth opening on the day of inclusion in the study (without treatment) with days 15, 30, 45, 60, 90 and 180 days, after the last injection of treatment, in the 3 arms of the study;;Compare the result of the mandibular functional limitation scale on the day of inclusion in the study (without treatment) with days 15, 30, 45, 60, 90 and 180 days, after the last injection of treatment, in the 3 arms of the study;Compare the use of rescue pain medication (paracetamol or dipyrone, quantified in mg/day) over time in the 3 study arms;To compare the profile of inflammatory cytokines present in the synovial fluid collected during each of the 3 injection procedures of the cycle, with 15-day intervals between each collection, in the 3 arms of the study.;Check the proportion of patients with grade 3 or 4 adverse reactions during and up to 30 days after the 12-week period from the start of treatment, in the 3 arms of the study.;Check the number of deaths from any cause during the study, in the 3 study arms.	—

Measure

Time frame

To compare the characteristic intensity of pain on the day of inclusion in the study (without treatment) with days 15, 30, 45, 60, 90 and 180 days, after the last injection of treatment, in participants submitted to the 3 arms of the study.;Compare the maximum pain-free mouth opening on the day of inclusion in the study (without treatment) with days 15, 30, 45, 60, 90 and 180 days, after the last injection of treatment, in the 3 arms of the study;;Compare the result of the mandibular functional limitation scale on the day of inclusion in the study (without treatment) with days 15, 30, 45, 60, 90 and 180 days, after the last injection of treatment, in the 3 arms of the study;Compare the use of rescue pain medication (paracetamol or dipyrone, quantified in mg/day) over time in the 3 study arms;To compare the profile of inflammatory cytokines present in the synovial fluid collected during each of the 3 injection procedures of the cycle, with 15-day intervals between each collection, in the 3 arms of the study.;Check the proportion of patients with grade 3 or 4 adverse reactions during and up to 30 days after the 12-week period from the start of treatment, in the 3 arms of the study.;Check the number of deaths from any cause during the study, in the 3 study arms.

—

Primary

Measure	Time frame
To compare the repair of articular bone tissue through initial (without treatment) and final computed tomography scans, 6 months after the last injection of treatment, in participants from the 3 study arms;	—

Countries

Brazil

Contacts

Public ContactRicardo Tesch

Faculdade de Medicina de Petrópolis/Centro Universitário Arthur Sá Earp Neto

ricardotesch@prof.unifase-rj.edu.br+55(24)2244-6464

Outcome results

None listed

Source: REBEC (via WHO ICTRP)