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

January 31, 2024 updated by: University of Florida

A Randomized, Double-Blind Study of the Efficacy of Platelet-Rich Growth Factor (PRGF) Supplementation Compared to Steroid Supplementation After Temporomandibular Joint (TMJ) Arthrocentesis in Female Patients With TMJ Osteoarthritis (OA)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Temporomandibular disorders (TMD) are musculoskeletal disorders that are commonly encountered, with pain in the temporomandibular joint (TMJ) and jaw closing muscles. Pain that involves the temporomandibular joint includes inflammatory pathologies such as arthritides, painful disk displacements and many times have an overlay of psychosocial comorbidities due to the uncontrolled pain. TMJ osteoarthritis is an intracapsular condition affecting the temporomandibular joint and presents with remodeling of the TMJ articulating tissues including the condyle and articular eminence secondary to inflammation resulting in intracapsular pain. There is a paucity of information regarding the relative effectiveness of different therapies for the treatment of patients with TMJ osteoarthritis. The identification of the least invasive and most efficacious therapy is vital to proper management of these patients with temporomandibular joint pain and disability. The purpose of this study is to establish the relative efficacy of TMJ arthrocentesis with steroid supplementation (a known effective therapy) compared to TMJ arthrocentesis with a supplement of plasma rich in growth factors (PRGF) for patients with TMJ osteoarthritis. Plasma rich in growth factors is isolated from the patient's own blood and injected into the temporomandibular joint to activate stem cells that may restore some of the articulating tissues that were lost during degeneration changes within the joint secondary to osteoarthritis. Pain and disability will be assessed using standard pain and physical measures that are recorded before and after treatment. Patients enrolled into the study will be examined and treated at the Department of Oral and Maxillofacial Surgery Faculty/Resident clinic. At the first appointment, they will be examined following standard procedures (medical history, physical exam, imaging by cone beam computerized tomography (CBCT)) to determine their diagnosis(es) and if they would potentially benefit from the TMJ arthrocentesis procedure. If the patient meets the inclusion criteria for the study and with their informed consent on the day of their TMJ arthrocentesis procedure, they will be required to have a pregnancy test if below age 60 and complete a questionnaire about their physical and pain symptoms and undergo a standardized clinical exam. The patients will then undergo the standard clinical protocol for TMJ arthrocentesis followed by either a 2 cc steroid/bupivacaine hydrochloride supplementation (standard treatment group) or a 2 cc PRGF supplementation (experimental group) into the TMJ. Follow-up appointments will be conducted at 1 month, 3 months and 6 months when the pain VAS measures and a clinical exam will be assessed. If patients have not experienced improvement in their primary outcome measure (TMJ pain) at the 3 month evaluation, the patient will have a second TMJ arthrocentesis procedure that will be supplemented with the alternative medication/growth factors (steroid or PRGF) using a cross-over design. Data from these patients will be analyzed separately from patients that complete the six month study. Also at 6 months, a second CBCT image of the temporomandibular joints will be obtained to determine the extent of bone remodeling within the TMJ. The results of this study should provide new information on the efficacy of PRGF supplementation for management of temporomandibular joint osteoarthritis.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female
  • 40 - 80 years of age
  • Unilateral or bilateral TMJ arthralgia
  • Osteoarthritis diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
  • TMJ sounds (crepitus or click or both)
  • Mild-moderate masticatory muscle myalgia
  • History of non-surgical treatment for at least 6 weeks including such modalities as appliance therapy, NSAID therapy or physical modalities without resolution of pain

Exclusion Criteria:

  • Contraindication to sedation including pregnancy or medical history
  • Rheumatologic disorders causing arthritis of the temporomandibular joint (i.e., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
  • History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
  • History of steroid injection in TMJ
  • TMJ pain greater than five years
  • History of narcotic drug use on a scheduled basis
  • Current active infection
  • Fibromyalgia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRGF Arm
The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.
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.
Active Comparator: Steroid Arm
Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.
Drug: Triamcinolone Acetonide
After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.
Other Names:
  • Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale Measurement (VAS) of Intracapsular Pain Intensity
Time Frame: Baseline up to 6 months
To compare the VAS measure of intracapsular pain intensity before (baseline) and after the procedure. VAS measurement provides a range of scores from 0-100. A higher score indicates greater pain intensity.
Baseline up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Charles G. Widmer, DDS, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202000689-A
  • OCR40106 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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