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

Phase 2

Completed

• Conditions: Denture Stomatitis
• Interventions: Drug: garlic , nystatin

• Registration Number: NCT01198223
• Lead Sponsor: Qazvin University Of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-23
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-15
• Last Update Posted: 2010-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug: garlic extract, nystatin	garlic , nystatin	Drug: garlic extract 40mg/dl or nystatin suspension 100000 iu/ml tid for one month Patients had been clinically with denture stomatitis and confirmed by oral medicine specialist were selected for the study. Gender, age, medical history, erythema types, size, and other treatment used for this disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received garlic extract and second group used nystatin suspension for 1 month. Each patients was examined at the beginning of the therapy ,and then every 1 weeks up to 1 months .

Primary Outcome Measures

Name	Time	Method
reduction of diameter of erythematous lesion under denture	first week	measuring erythematous lesion by visual and then photography and a colis

Secondary Outcome Measures

Name	Time	Method
complete relief of erythematous lesions	fourth week

Trial Locations

Locations (1)

QUMS; 🇮🇷 Qazvin, Iran, Islamic Republic of