Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease (NCT00471393) | Clinical Trial Compass
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 range18 Years – 45 Years
SexFEMALE
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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…
What they're measuring
1
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.