An interventional study of Gel in Recurrent Aphthous Ulcer and Recurrent Aphthous Stomatitis, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Shahid Beheshti University of Medical Sciences · Not applicable, Interventional, and Treatment
Recurrent aphthous ulcer is a painful inflammatory lesion with a high prevalence. Since the etiology is not clear, several strategies have been proposed to reduce pain and severity of its symptoms. Today, curcumin is considered as an herbal medicine with anti-inflammatory properties. Treatment or control of various inflammatory diseases has been proposed, but its low solubility in water has reduced bioavailability, while the use of nanoparticle pharmaceutical techniques has been able to solve these problems. Therefore, the aim of the present study was to evaluate the clinical efficacy of a new topical curcumin gel with nano-technology and compare it with 2% curcumin gel in patients with recurrent aphthous ulcers.
This randomized clinical trial was performed on 48 patients assigned to two groups (nano-curcumin gel) and (curcumin gel). Before treatment, the size of the wound and VAS were measured. After intervention, the two variables were measured again on the fourth and seventh days , then the amount of improvement was quantitatively and qualitatively compared in the two groups and a significant level of less than 0.05 was considered.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 48 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
%2 Curcumin gel
Other: Gel
%1 NanoCurcumin gel
Other: Gel
containing herbal Curcumin or NanoCurcumin
Wound size
The ulcer size was evaluated by determining the distance between two opposed boundaries of the ulcer edge, using a periodontal probe in millimeters.
Time frame: one week
Pain score
Pain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome)
Time frame: one week
Plan to share: Undecided
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences →