Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis

Denture Stomatitis Clinical Trial

Official title:

Comparison of Therapeutic Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198223
• Other study ID #: QUMS 1234
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2010
• Last updated: October 15, 2010
• Start date: July 2010
• Est. completion date: October 2010

Study information

• Verified date: September 2010
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the present study was to compare the effect of aqueous extract of garlic with nystatin mouthwash in denture stomatitis.

Description:

Denture stomatitis is the most common form of chronic oral candidiasis manifested as chronic inflammation of the mucous membrane t supporting the movable prosthesis that may have a local or systemic nature. This inflammation is presented as mucous erythema and occasionally with pain and burning. The standard treatment for denture stomatitis is administration of nystatin which is accompanied with complications such as bitter taste as well as the high number of drug application that result in reduced tendency of patients in using this medication hence, efforts are continuously being made to substitute other types of therapies for this condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 40 years of age and older

• confirm of denture stomatitis by the oral medicine specialists

Exclusion Criteria:

• Patients with a history of using anti-fungal drugs, antibiotics, and corticosteroid within the previous month

• allergy to garlic and nystatin mouthwash

• immunodeficiency

• uncontrolled diabetes

• those with garlic rich diet

• inability in using mouthwash

• loose and discolored dentures

• psychologic disorder and alzheimer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Denture Stomatitis
• Stomatitis
• Stomatitis, Denture

Intervention

Drug:
• garlic , nystatin
mouthwash

Locations

Country	Name	City	State
Iran, Islamic Republic of	QUMS	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of diameter of erythematous lesion under denture	measuring erythematous lesion by visual and then photography and a colis	first week	Yes
Secondary	complete relief of erythematous lesions		fourth week	Yes