Recruiting
Phase 3

Hydrocortisone vs. Diclofenac

Sponsor:

University of the Pacific

Code:

NCT05816226

Conditions

TMJ Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hydrocortisone 2.5%

Diclofenac 1% topical

Study Details

Brief summary:

The goal of this clinical trial is to evaluate the efficacy of topical 2.5% hydrocortisone in TMJ arthralgia. The main questions it aims to answer are:

  • How does pain reduction compare?
  • How does improvement in jaw function limitation compare?
  • How do side effects compare? Participants will
  • On day 1 be examined and report their pain level and jaw function limitation
  • On days 1-21, apply their cream four times a day
  • On day 21, report their pain level, jaw function limitation, compliance with instructions, and side effects.

Researchers will compare topical 2.5% hydrocortisone and topical 1% diclofenac to see if efficacy and side effects differ.

Conditions

TMJ Pain

Study ID

NCT05816226

Start date

Jun 1, 2023

Status verified date

Dec, 2024

Completion date

Apr, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Arthralgia of at least 1 TMJ for at least 3 days

Exclusion Criteria:

  • Systemic pain condition
  • Past adverse reaction to steroid
  • Currently taking steroid
  • Taken steroid in the past ___ months
  • Muscle relaxants (may start after study is complete)
  • New night guard during study, or within 1 month of start of study (may start after study is complete)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydrocortisone topical

2.5% hydrocortisone cream

active comparator: Diclofenac topical

1% diclofenac cream

Interventions

Hydrocortisone 2.5%

Applied four times daily to TMJ with arthralgia

Diclofenac 1% topical

Applied four times daily to TMJ with arthralgia

Primary outcome measure

  • Change in pain intensity [ Time Frame: Pain measured on days 1 and 21 ]
  • Change in jaw function limitation [ Time Frame: Jaw function limitation measured on days 1 and 21 ]

Central Contacts and Locations

Central contacts

Andrew Young, DDS, MSD

4153517126ayoung@pacific.edu

Locations

Arthur A. Dugoni School of Dentistry, University of the Pacific

Recruiting

San Francisco, California, United States, 94103

Contacts

Andrew Young, DDS, MSD

4159296611ayoung@pacific.edu

More Information

Sponsor

University of the Pacific

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Keywords

  • diclofenac
  • hydrocortisone
  • TMJ
  • arthralgia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of the Pacific on 2024-12-11.