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

NCT04731233 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: IRB202000689-AOCR40106
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

TMJ; Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating

  The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).

  Three Months

• Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating

  The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).

  Six Months

Other Outcomes (4)

• Chewing Pain Measured by Visual Analog Scale (VAS)

  Baseline

• Chewing Pain Measured by Visual Analog Scale (VAS)

  Six Months

• Temporomandibular Joint Crepitus

  Baseline

Study Arms (2)

PRGF Arm

EXPERIMENTAL

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

Steroid Arm

ACTIVE COMPARATOR

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

Interventions

Plasma Rich in Growth Factor (PRGF) Supplementation BIOLOGICAL

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.

PRGF Arm

Triamcinolone Acetonide DRUG

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

Also known as: Kenalog

Steroid Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Only females will be studied since greater than 95% of the patients that pursue temporomandibular joint arthrocentesis are female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Intercellular Signaling Peptides and Proteins; Dietary Supplements; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Due to the limited number of participants in this clinical trial, the study was terminated, and a statistical analysis was not conducted.

Results Point of Contact

• Title: Dr. Charles G. Widmer
• Organization: University of Florida

widmer@dental.ufl.edu

352-273-5696

Study Officials

• Charles G. Widmer, DDS

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: March 30, 2021
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)