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

October 15, 2010 updated by: Qazvin University Of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 .
Drug: garlic , nystatin
mouthwash
Other Names:
  • aquous garlic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of diameter of erythematous lesion under denture
Time Frame: first week
measuring erythematous lesion by visual and then photography and a colis
first week

Secondary Outcome Measures

Outcome Measure
Time Frame
complete relief of erythematous lesions
Time Frame: fourth week
fourth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qazvin University Of Medical Sciences

Investigators

  • Study Chair: mahin bakhshi, DDS,MS, Qazvin university of medical science
  • Study Director: Jamileh bigom Taheri, DDS/MS, Shahid Beheshti University of Medical Science
  • Principal Investigator: Samira Basir Shabestari, DDS/MS, QUMS
  • Principal Investigator: Rozbeh Pahlevan, DDS, QUMS
  • Principal Investigator: Anet Tanic, DDS, QUMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

October 18, 2010

Last Update Submitted That Met QC Criteria

October 15, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUMS 1234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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