Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2026-01-06 @ 12:53 AM
Study NCT ID:
NCT00471393
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2007-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
Double-blind Randomized Clinical Study on Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease in Women.
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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:
* To compare the efficacy of placebo and diclofenac topical PLO gel in terms of functional pain intensity of symptomatic temporomandibular degenerative joint disease in participants by comparing baseline measures obtained prior to commencement of the study, with the measurements obtained at 30, 60 and 90 days during the treatment intervention through the use of a Visual Analogue Scale (VAS).
Secondary Objectives:
* To compare the efficacy of placebo and diclofenac topical in PLO gel in terms of measurement of the range of motion of voluntary and assisted vertical jaw opening of symptomatic temporomandibular degenerative joint disease (TMDJD) in participants by comparing baseline measures obtained prior to commencement of the study, Time 0, through the use of a 100 mm ruler to measures obtained at 30, 60 and 90 days during the treatment intervention.
* To compare the efficacy of placebo and diclofenac in terms of effect on quality of life of symptomatic TMDJD in participants by comparing baseline measures obtained prior to commencement of the study, Time 0, to measures obtained after 90 consecutive days of treatment, utilizing a subsection of The Brief Pain Inventory Scale (BPI) which relates to quality of life.
* To compare the efficacy of placebo and diclofenac in terms of effect on pain intensity of symptomatic TMDJD in participants by comparing baseline measures obtained prior to commencement of the study, Time 0, to measures obtained after 90 consecutive days of treatment, utilizing a subsection of The Brief Pain Inventory Scale (BPI) (Cleeland \& Ryan, 1994) which relates to pain intensity.
* To compare the efficacy of placebo and diclofenac topical PLO gel in terms of effect on disability on specific activities of daily living of TMDJD participants by comparing baseline measures obtained prior to the commencement of the study, Time 0, to that obtained after 90 consecutive day of treatment, utilizing The Pain Disability Index (PDI) (Bush \& Harkin, 1995).
Tertiary Objectives
* To compare the adverse effects documented by the topical diclofenac group to those documented by the topical placebo group.
* To compare the amount of breakthrough medication used by the topical diclofenac group versus the placebo group in order to assess if the use of topical diclofenac reduces the amount of oral medication.
* To compare reasons for withdrawal from the study between topical placebo and topical diclofenac groups.
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.
Primary Objectives:
* To compare the efficacy of placebo and diclofenac topical PLO gel in terms of functional pain intensity of symptomatic temporomandibular degenerative joint disease in participants by comparing baseline measures obtained prior to commencement of the study, with the measurements obtained at 30, 60 and 90 days during the treatment intervention through the use of a Visual Analogue Scale (VAS).
Secondary Objectives:
* To compare the efficacy of placebo and diclofenac topical in PLO gel in terms of measurement of the range of motion of voluntary and assisted vertical jaw opening of symptomatic temporomandibular degenerative joint disease (TMDJD) in participants by comparing baseline measures obtained prior to commencement of the study, Time 0, through the use of a 100 mm ruler to measures obtained at 30, 60 and 90 days during the treatment intervention.
* To compare the efficacy of placebo and diclofenac in terms of effect on quality of life of symptomatic TMDJD in participants by comparing baseline measures obtained prior to commencement of the study, Time 0, to measures obtained after 90 consecutive days of treatment, utilizing a subsection of The Brief Pain Inventory Scale (BPI) which relates to quality of life.
* To compare the efficacy of placebo and diclofenac in terms of effect on pain intensity of symptomatic TMDJD in participants by comparing baseline measures obtained prior to commencement of the study, Time 0, to measures obtained after 90 consecutive days of treatment, utilizing a subsection of The Brief Pain Inventory Scale (BPI) (Cleeland \& Ryan, 1994) which relates to pain intensity.
* To compare the efficacy of placebo and diclofenac topical PLO gel in terms of effect on disability on specific activities of daily living of TMDJD participants by comparing baseline measures obtained prior to the commencement of the study, Time 0, to that obtained after 90 consecutive day of treatment, utilizing The Pain Disability Index (PDI) (Bush \& Harkin, 1995).
Tertiary Objectives
* To compare the adverse effects documented by the topical diclofenac group to those documented by the topical placebo group.
* To compare the amount of breakthrough medication used by the topical diclofenac group versus the placebo group in order to assess if the use of topical diclofenac reduces the amount of oral medication.
* To compare reasons for withdrawal from the study between topical placebo and topical diclofenac groups.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: