Curcumin and Nanocurcumin in Oral Aphthous Ulcer

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Curcumin and NanoCurcumin in Recurrent Aphthous Stomatitis

Conditions
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Recurrent Aphthous Ulcer, Recurrent Aphthous Stomatitis

Intervention / Treatment
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* Other: Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with minor and recurrent aphthous ulcer lesions within 48 hours and Aphthous like Lesions Exclusion Criteria: Wounds are in inaccessible areas (such as posterior palate). If a person suffers from systemic disease (through questioning the patient) Patients with turmeric allergy and any type of gel used in this study. Pregnant or lactating women .. accompany with other mucosal lesions. Do not take any other medicine while taking intervention Major or herpeti form of aphthous ulcer
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Curcumin<br>%2 Curcumin gel | Other: Gel<br>* containing herbal Curcumin or NanoCurcumin<br>|
| Active Comparator: Nanocurcumin<br>%1 NanoCurcumin gel | Other: Gel<br>* containing herbal Curcumin or NanoCurcumin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Aphthous Stomatitis, Curcumin, Nanocurcumin, management