Your session is about to expire
← Back to Search
Corticosteroid
PRGF Supplementation for Temporomandibular Joint Disorder
Phase 4
Waitlist Available
Led By Charles G. Widmer, DDS
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unilateral or bilateral TMJ arthralgia
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 months
Awards & highlights
Study Summary
This trial will compare the effectiveness of two treatments for temporomandibular joint osteoarthritis, one with a steroid and one with platelet-rich growth factor supplementation.
Who is the study for?
This trial is for women aged 40-80 with mild to moderate jaw muscle pain, TMJ joint pain, and osteoarthritis diagnosed by specific criteria. They must have tried non-surgical treatments like mouth appliances or NSAIDs without relief. Excluded are those with active infections, fibromyalgia, recent steroid injections in the TMJ, chronic narcotic use, rheumatologic disorders affecting the TMJ, contraindications to sedation (including pregnancy), long-term TMJ pain over five years or previous TMJ procedures.Check my eligibility
What is being tested?
The study tests if injecting growth factors (PRGF) into the jaw joint after a cleaning procedure (arthrocentesis) is better than using a steroid (Triamcinolone Acetonide). It's a head-to-head comparison in patients with jaw arthritis to see which treatment reduces inflammation and pain more effectively.See study design
What are the potential side effects?
Possible side effects of PRGF may include discomfort at injection site or infection. Triamcinolone could cause increased appetite, mood changes, trouble sleeping; long-term use might lead to bone thinning or weight gain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have pain in one or both of my jaw joints.
Select...
I am female.
Select...
I am between 40 and 80 years old.
Select...
I have been diagnosed with osteoarthritis in my jaw.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Analog Scale Measurement (VAS) of Intracapsular Pain Intensity
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PRGF ArmExperimental Treatment1 Intervention
The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.
Group II: Steroid ArmActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,691 Total Patients Enrolled
14 Trials studying Osteoarthritis
11,130 Patients Enrolled for Osteoarthritis
Charles G. Widmer, DDSPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pain in one or both of my jaw joints.I have a condition like rheumatoid arthritis affecting my jaw joint.I have an active infection.I have been diagnosed with fibromyalgia.I am female.I am between 40 and 80 years old.I have been diagnosed with osteoarthritis in my jaw.I've tried non-surgical treatments like medication or physical therapy for over 6 weeks without pain relief.My jaw makes noises like clicking or grinding.I have had a TMJ surgery or procedure before.I have received a steroid injection in my jaw joint.I have mild to moderate jaw muscle pain.I have had TMJ pain for more than five years.I cannot be sedated due to pregnancy or my medical history.
Research Study Groups:
This trial has the following groups:- Group 1: PRGF Arm
- Group 2: Steroid Arm
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04731233 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the current research protocol allow elderly people to participate?
"The age range eligibility for this trial is 40 to 80 years old."
Answered by AI
What ailments are frequently managed by PRGF Supplementation?
"PRGF Supplementation is mainly utilized to treat ulcerative colitis, but has been noted as a successful treatment option for hand, brain and dermatologic maladies."
Answered by AI
Could you elaborate on previous experiences with the use of Plasma Rich in Growth Factor (PRGF) Supplementation?
"Presently, 41 trials examining Plasma Rich in Growth Factor (PRGF) Supplementation are active, with 8 of them currently residing in Phase 3. A variety of medical centres across 75 different locations have opened up their doors for clinical studies on this therapy. Of the many sites offering these investigations, most reside within Columbia Missouri."
Answered by AI
Are there vacancies available for participants of this experiment?
"According to the data posted on clinicaltrials.gov, this medical trial is open for recruitment. The study was first made available on March 30th 2021 and most recently updated January 14th 2022."
Answered by AI
What is the scale of participation for this clinical research?
"Right, the clinicaltrials.gov website shows that this experiment is presently enrolling patients. This investigation was originally advertised on March 30th 2021 and its parameters were last modified on January 14th 2022. 36 volunteers must be enlisted from a single site."
Answered by AI
Has the FDA sanctioned Plasma Rich in Growth Factor (PRGF) for medical use?
"In light of its regulatory approval status, Plasma Rich in Growth Factor (PRGF) Supplementation has been rated as a 3 on the safety scale by Power."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Louisiana
West Virginia
How old are they?
65+
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
All my joints ache, elbows, knees, fingers.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger