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

This study has been completed.
Sponsor:
Information provided by:
Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01198223
First received: August 23, 2010
Last updated: October 15, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Denture Stomatitis
Drug: garlic , nystatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Therapeutic Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • reduction of diameter of erythematous lesion under denture [ Time Frame: first week ] [ Designated as safety issue: Yes ]
    measuring erythematous lesion by visual and then photography and a colis


Secondary Outcome Measures:
  • complete relief of erythematous lesions [ Time Frame: fourth week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: aquous garlic

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01198223

Locations
Iran, Islamic Republic of
QUMS
Qazvin, Iran, Islamic Republic of
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Comparison of therapeutic effect of aqueous extract of garlic and nystatin mouthwash in denture stomatitis, Qazvin University of Medical Science
ClinicalTrials.gov Identifier: NCT01198223     History of Changes
Other Study ID Numbers: QUMS 1234
Study First Received: August 23, 2010
Last Updated: October 15, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Qazvin University Of Medical Sciences:
denture stomatitis
nystatin
garlic

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

ClinicalTrials.gov processed this record on October 19, 2014