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Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis

NCT04731233 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-02-21

Study results available
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Summary

Temporomandibular joint (TMJ) osteoarthritis (OA) affects articulating tissues secondary to inflammation resulting in intracapsular pain. This prospective, double-blind randomized clinical trial will evaluate the relative efficacy of TMJ arthrocentesis with a supplementation of platelet-rich growth factors (PRGF) compared to TMJ arthrocentesis with a steroid supplementation (a known effective therapy) for patients with TMJ OA.

Conditions

Interventions

BIOLOGICAL

Plasma Rich in Growth Factor (PRGF) Supplementation

After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes.

DRUG

Triamcinolone Acetonide

After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Charles G. Widmer, DDS · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2024-02-21
Completion
2024-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04731233 on ClinicalTrials.gov