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

NCT01198223 | Completed Phase 2 DMC

• 1 other identifier: QUMS 1234
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Denture Stomatitis

Keywords

denture stomatitis; nystatin; garlic

Outcome Measures

Primary Outcomes (1)

• reduction of diameter of erythematous lesion under denture

  measuring erythematous lesion by visual and then photography and a colis

  first week

Secondary Outcomes (1)

• complete relief of erythematous lesions

  fourth week

Study Arms (1)

drug: garlic extract, nystatin

OTHER

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

Interventions

garlic , nystatin DRUG

mouthwash

Also known as: aquous garlic

drug: garlic extract, nystatin

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• confirm of denture stomatitis by the oral medicine specialists

You may not qualify if:

• 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

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

QUMS

Qazvin, Qazvin Province, Iran

Location

MeSH Terms

Conditions

Stomatitis, Denture

Interventions

Nystatin

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• mahin bakhshi, DDS,MS

  Qazvin University of Medical Science

  STUDY CHAIR

• Jamileh bigom Taheri, DDS/MS

  Shahid Beheshti University of Medical Science

  STUDY DIRECTOR

• Samira Basir Shabestari, DDS/MS

  QUMS

  PRINCIPAL INVESTIGATOR

• Rozbeh Pahlevan, DDS

  QUMS

  PRINCIPAL INVESTIGATOR

• Anet Tanic, DDS

  QUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: September 10, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 18, 2010

Record last verified: 2010-09

Locations

IR (1)