Curcumin and Nanocurcumin in Oral Aphthous Ulcer

NCT04385979 | Completed DMC

• 1 other identifier: SBMU1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Aphthous Ulcer; Recurrent Aphthous Stomatitis

Keywords

Recurrent Aphthous Stomatitis; Curcumin; Nanocurcumin; management

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Curcumin

ACTIVE COMPARATOR

%2 Curcumin gel

Other: Gel

Nanocurcumin

ACTIVE COMPARATOR

%1 NanoCurcumin gel

Other: Gel

Interventions

Gel OTHER

containing herbal Curcumin or NanoCurcumin

Curcumin; Nanocurcumin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with minor and recurrent aphthous ulcer lesions within 48 hours and Aphthous like Lesions

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Mahinbakhshi@Sbmu.Ac.Ir

Tehran, 0098, Iran

Location

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

Gels

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 13, 2020
• Study Start: July 15, 2018
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

IR (1)