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

Primary Purpose

Denture Stomatitis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
garlic , nystatin
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Denture Stomatitis focused on measuring denture stomatitis, nystatin, garlic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • QUMS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

drug: garlic extract, nystatin

Arm Description

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 .

Outcomes

Primary Outcome Measures

reduction of diameter of erythematous lesion under denture
measuring erythematous lesion by visual and then photography and a colis

Secondary Outcome Measures

complete relief of erythematous lesions

Full Information

First Posted
August 23, 2010
Last Updated
October 15, 2010
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01198223
Brief Title
Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
Official Title
Comparison of Therapeutic Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Denture Stomatitis
Keywords
denture stomatitis, nystatin, garlic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drug: garlic extract, nystatin
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
garlic , nystatin
Other Intervention Name(s)
aquous garlic
Intervention Description
mouthwash
Primary Outcome Measure Information:
Title
reduction of diameter of erythematous lesion under denture
Description
measuring erythematous lesion by visual and then photography and a colis
Time Frame
first week
Secondary Outcome Measure Information:
Title
complete relief of erythematous lesions
Time Frame
fourth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mahin bakhshi, DDS,MS
Organizational Affiliation
Qazvin University of Medical Science
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jamileh bigom Taheri, DDS/MS
Organizational Affiliation
Shahid Beheshti University of Medical Science
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samira Basir Shabestari, DDS/MS
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rozbeh Pahlevan, DDS
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anet Tanic, DDS
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
QUMS
City
Qazvin
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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