Clinical Trial Finder

Topical Treatment for TMJ Arthralgia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05816226
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of the Pacific
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 TMJ Pain
Additional Details

  • - Person 2 will label creams, patient packets (pre-stamped envelope, questionnaire, consent form), and give packets to Person 1 in the order in which they are to be dispensed.
  • - Person 1 will recruit all eligible patients in the order in which they are seen, enrolling all that consent.
Packets and gel will be given to patient, and written and verbal instructions, including that email will be sent saying "Keep it up!" to remind them to continue applying get, as well as "Please send us your questionnaire". Consent forms will be stored in locked drawer.
  • - Person 1 will remind patient on days 7 and 14 to continue with the study.
  • - Person 1 will remind patient on day 21 to mail back the completed questionnaire.
  • - Person 1 will reach out to all patients from whom the questionnaire is not returned within 1 week of day 21, and do so at weekly intervals a minimum of 3 times.
  • - Person 1 will enter data in Excel as it comes, reaching out to patients if there are questions.
Excel file uses random number ID, not patient name, thereby anonymizing the data.
  • - Persons 1, 2, 3, and 4 will decide which patient's data, if any, should be removed.
  • - Person 1 will send complete anonymized Excel data file (containing all patients) to Person 3.
  • - Person 2 will determine, using random number generator, which group will be referred to as "Group A" during the statistical analysis, and which will be referred to as "Group B" - Person 2 will tell Dr.
Korczeniewska which data will be in Group A, and which will be in Group B.
  • - Person 3 will perform statistical analysis.
- Person 2 will reveal which group was Hydrocortisone, and which was Diclofenac

Arms & Interventions

Arms

Experimental: Hydrocortisone topical

2.5% hydrocortisone cream

Active Comparator: Diclofenac topical

1% diclofenac cream

Interventions

Drug: - Hydrocortisone 2.5%

Applied four times daily to TMJ with arthralgia

Drug: - Diclofenac 1% topical

Applied four times daily to TMJ with arthralgia

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Francisco, California

Status

Recruiting

Address

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

San Francisco, California, 94103

Site Contact

Andrew Young, DDS, MSD

[email protected]

4159296611

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