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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

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

NCT ID

NCT01198223

First Posted

August 23, 2010

Last Updated

October 15, 2010

Sponsor

Qazvin University Of Medical Sciences

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

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

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: