Curcumin and Nanocurcumin in Oral Aphthous Ulcer

Not Applicable

Completed

• Conditions: Recurrent Aphthous Ulcer; Recurrent Aphthous Stomatitis
• Interventions: Other: Gel

• Registration Number: NCT04385979
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-15
• Primary Completion: 2019-01-01
• Study Completion: 2020-03-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-08
• Last Update Submitted: 2020-05-08
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin	Gel	%2 Curcumin gel
Nanocurcumin	Gel	%1 NanoCurcumin gel

Primary Outcome Measures

Name	Time	Method
Pain score	one week	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)
Wound size	one week	The ulcer size was evaluated by determining the distance between two opposed boundaries of the ulcer edge, using a periodontal probe in millimeters.

Trial Locations

Locations (1)

Mahinbakhshi@Sbmu.Ac.Ir; 🇮🇷 Tehran, Iran, Islamic Republic of