CompletedNot Applicable

Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease

Canada28 participantsStarted 2006-05

Plain-language summary

The use of a topical medication was compared to placebo to be applied over the symptomatic temporomandibular joint in women with the diagnosis of osteoarthritis of the temporomandibular joint(s). The hypothesis is to investigate whether the use of a topical anti-inflammatory medication when compared to the placebo would decrease the pain of the affected joint and/or increased mouth opening.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A baseline score of ≥ 3.0 cm on a 10 cm measured VAS (Visual Analogue Scale) according to the criteria established by Collins et al. (Collins, Moore, \& Mcquay, 1997) (for moderate and severe pain) required for participants prior to use of analgesics, in order to provide adequate sensitivity. * Females from the ages of 18 to 45 years of age inclusive. * Primary degenerative joint disease as diagnosed through radiographs utilizing volumetric cone beam computed tomographic images reformatted in axial, coronal, and sagittal views that will be assessed by an independent radiologist. Exclusion Criteria: * Nursing or expectant females or females planning on becoming pregnant. * Participants not clearly diagnosed as having symptomatic degenerative joint disease. * Participants having DJD secondarily to trauma, previous infection or general joint/muscle disease. * Participants who have experienced adverse reactions to any of the components of the formulation used in the study. * Participants who have evidence of periodontal disease, dental caries, oral pathology or infections of the oral cavity. * Participants with a history of neuropathic pain in the orofacial region. * Participants scheduled for surgery in the near future. * Participants currently undergoing orthodontic treatment. * Participants with a history of epilepsy, cardiovascular disease, renal disease/disorder, hepatic disease/disorder, glaucoma, bowel obstruction, urinary retention, diabetes, hype…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1.To compare the efficacy of topical placebo and topical diclofenac in functional pain intensity at commencement of the study, Day 30, Day 60 and Day 90 through the use of VAS.

Timeframe: 90 days

Trial details

NCT IDNCT00471393

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Temporomandibular Degenerative Joint Disease trials