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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198223
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : October 18, 2010
Information provided by:
Qazvin University Of Medical Sciences

August 23, 2010
September 10, 2010
October 18, 2010
July 2010
September 2010   (Final data collection date for primary outcome measure)
reduction of diameter of erythematous lesion under denture [ Time Frame: first week ]
measuring erythematous lesion by visual and then photography and a colis
Same as current
Complete list of historical versions of study NCT01198223 on Archive Site
complete relief of erythematous lesions [ Time Frame: fourth week ]
Same as current
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Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Denture Stomatitis
Drug: garlic , nystatin
Other Name: aquous garlic
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 .
Intervention: Drug: garlic , nystatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
QUMS 1234
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Comparison of therapeutic effect of aqueous extract of garlic and nystatin mouthwash in denture stomatitis, Qazvin University of Medical Science
Qazvin University Of Medical Sciences
Not Provided
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
Qazvin University Of Medical Sciences
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP