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

NCT ID: NCT01198223

Last Updated: 2010-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Denture Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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drug: garlic extract, 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 .

Group Type OTHER

garlic , nystatin

Intervention Type DRUG

mouthwash

Interventions

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garlic , nystatin

mouthwash

Intervention Type DRUG

Other Intervention Names

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aquous garlic

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qazvin University Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Qazvin University of Medical Science

Principal Investigators

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mahin bakhshi, DDS,MS

Role: STUDY_CHAIR

Qazvin University of Medical Science

Jamileh bigom Taheri, DDS/MS

Role: STUDY_DIRECTOR

Shahid Beheshti University of Medical Science

Samira Basir Shabestari, DDS/MS

Role: PRINCIPAL_INVESTIGATOR

QUMS

Rozbeh Pahlevan, DDS

Role: PRINCIPAL_INVESTIGATOR

QUMS

Anet Tanic, DDS

Role: PRINCIPAL_INVESTIGATOR

QUMS

Locations

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QUMS

Qazvin, Qazvin Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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QUMS 1234

Identifier Type: -

Identifier Source: org_study_id