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| Descriptive Information Fields | |||||
| Brief Title † | Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease | ||||
| Official Title † | Double-Blind Randomized Clinical Study on Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease in Women. | ||||
| Brief 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. |
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| Detailed Description | The purpose of this study is to measure the efficacy of topical diclofenac to topical placebo in the symptomatic relief of degenerative temporomandibular joint disease in a female population between the ages of 18-45 years of age. Primary Objectives:
Secondary Objectives:
Tertiary Objectives
The null hypothesis is that there is no difference between the efficacy of topical diclofenac and topical placebo in the treatment of degenerative temporomandibular joint disease. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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. [ Time Frame: 90 days ] | ||||
| Secondary Outcome Measure † | 1.To compare the efficacy of topical placebo and topical diclofenac in voluntary and assisted vertical jaw opening through the use of a 100 mm ruler from commencement of the study, Day 30, Day 60 and Day 90. [ Time Frame: 90 days ] 2.To compare the efficacy of topical placebo and topical diclofenac on the effect on quality of life by comparing measures at the commencement of the study to the end of treatment, through use of a subsection of The Brief Pain Inventory Scale (BPI). [ Time Frame: 90 days ] 3.To compare the efficacy of topical placebo and topical diclofenac on pain intensity by comparing measures obtained at the commencement of the study, to those obtained at the end using a subsection of The Brief Pain Inventory Scale. [ Time Frame: 90 days ] 4.To compare the efficacy of topical placebo and topical diclofenac on the disability on specific activities of daily living by comparing baseline measures, to that obtained at the end of treatment, utilizing The Pain Disability Index. [ Time Frame: 90 days ] 5.To compare the adverse effects documented by the topical diclofenac group to those documented by the topical placebo group. [ Time Frame: 90 days ] 6.To compare the amount of breakthrough medication used by the topical diclofenac group versus the topical placebo group in order to assess if the use of topical diclofenac reduces the amount of oral medication. [ Time Frame: 90 days ] |
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| Condition † | Temporomandibular Degenerative Joint Disease. | ||||
| Intervention † | Drug: 1.5% diclofenac in 45.5% DMSO (topical treatment) Drug: 45.5% DMSO (topical placebo) |
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| MEDLINE PMIDs | 15317652, 15147585, 9487165, 15477437, 15468367, 16511925 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 28 | ||||
| Start Date † | May 2006 | ||||
| Completion Date | April 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00471393 | ||||
| Organization ID | FMW 5936 | ||||
| Secondary IDs †† | File #103090 Health Canada, Grant#2005-04 | ||||
| Study Sponsor † | University of Alberta, Graduate Orthodontic Program | ||||
| Collaborators †† | University of Alberta | ||||
| Investigators † |
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| Information Provided By | University of Alberta, Graduate Orthodontic Program | ||||
| Verification Date | May 2007 | ||||
| First Received Date † | May 7, 2007 | ||||
| Last Updated Date | May 7, 2007 | ||||