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

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

Condition or disease Intervention/treatment Phase
Denture Stomatitis Drug: garlic , nystatin Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Therapeutic Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
Study Start Date : July 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
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
Other Name: aquous garlic

Primary Outcome Measures :
  1. reduction of diameter of erythematous lesion under denture [ Time Frame: first week ]
    measuring erythematous lesion by visual and then photography and a colis

Secondary Outcome Measures :
  1. complete relief of erythematous lesions [ Time Frame: fourth week ]

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198223

Iran, Islamic Republic of
Qazvin, Iran, Islamic Republic of
Sponsors and Collaborators
Qazvin University Of Medical Sciences
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

Responsible Party: Comparison of therapeutic effect of aqueous extract of garlic and nystatin mouthwash in denture stomatitis, Qazvin University of Medical Science Identifier: NCT01198223     History of Changes
Other Study ID Numbers: QUMS 1234
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: October 18, 2010
Last Verified: September 2010

Keywords provided by Qazvin University Of Medical Sciences:
denture stomatitis

Additional relevant MeSH terms:
Stomatitis, Denture
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action