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Nonsteroidal Anti-inflammatory Drug (NSAID)

Topical Creams for TMJ Pain

Phase 3

Recruiting

Research Sponsored by University of the Pacific

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Arthralgia of at least 1 TMJ for at least 3 days

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pain measured on days 1 and 21

Awards & highlights

Study Summary

This trial tests a cream to reduce TMJ pain & improve jaw function. Participants report pain, jaw function, side effects & compliance. Researchers compare the cream to another.

Who is the study for?

This trial is for individuals experiencing pain in at least one temporomandibular joint (TMJ) for a minimum of three days. It's not suitable for those with systemic pain conditions, past steroid reactions, current or recent steroid use, or those who've started using muscle relaxants or a new night guard around the study period.Check my eligibility

What is being tested?

The trial tests the effectiveness of two topical treatments: hydrocortisone (2.5%) and diclofenac (1%) on TMJ arthralgia. Participants will apply their assigned cream four times daily over three weeks to compare pain reduction, jaw function improvement, and side effects.See study design

What are the potential side effects?

Potential side effects may include skin irritation at the application site, increased risk of infection due to immune suppression from steroids like hydrocortisone, and possible systemic absorption leading to broader steroid-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had jaw joint pain for at least 3 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pain measured on days 1 and 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pain measured on days 1 and 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and pain measured on days 1 and 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in jaw function limitation

Change in pain intensity

Secondary outcome measures

Number of participants with side effects

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hydrocortisone topicalExperimental Treatment1 Intervention

2.5% hydrocortisone cream

Group II: Diclofenac topicalActive Control1 Intervention

1% diclofenac cream

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of the PacificLead Sponsor

13 Previous Clinical Trials

646 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are contributing to the research of this experiment?

"Affirmative. The data available on clinicaltrials.gov reveals that this medical study, which was first posted on June 1st 2023, is actively recruiting participants. As such, 90 individuals are being sought from one single centre for the trial."

Answered by AI

Are recruitment efforts ongoing for this research study?

"Based on the clinicaltrials.gov portal, it is confirmed that this medical study commencing June 1st 2023 and last updated October 11th 2023 is currently recruiting participants."

Answered by AI

Are there potential risks associated with utilizing Hydrocortisone topically?

"Our team at Power has assigned Hydrocortisone topical a score of 3, owing to the existent clinical evidence that demonstrates its efficacy as well as the multiple safety assessments conducted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical Treatment for TMJ Arthralgia

Andrew Young 2023. "Topical Treatment for TMJ Arthralgia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05816226.