Denture StomatitisPhase 2NCT01198223
Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
A Phase 2 study testing garlic , nystatin in people with Denture Stomatitis, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
The aim of the present study was to compare the effect of aqueous extract of garlic with nystatin mouthwash in denture stomatitis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Denture Stomatitis
- What is being tested?
- garlic , nystatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Jul 2010to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age and older
- confirm of denture stomatitis by the oral medicine specialists
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Therapeutic Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
The aim of the present study was to compare the effect of aqueous extract of garlic with nystatin mouthwash in denture stomatitis.
Read the 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.
- Conditions
- Denture Stomatitis
- Being tested
- garlic , nystatin
- Keywords
- denture stomatitis, nystatin, garlic
- Medical subject headings
- Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
garlic , nystatinDrug
Also called aquous garlic
mouthwash
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Drug: garlic , nystatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of diameter of erythematous lesion under denture
measuring erythematous lesion by visual and then photography and a colis
Measured: first week
Secondary outcomes (1)
complete relief of erythematous lesions
Measured: fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- mahin bakhshi, DDS,MS, Study chair, Qazvin University of Medical ScienceJamileh bigom Taheri, DDS/MS, Study director, Shahid Beheshti University of Medical ScienceSamira Basir Shabestari, DDS/MS, Principal investigator, QUMSRozbeh Pahlevan, DDS, Principal investigator, QUMSAnet Tanic, DDS, Principal investigator, QUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198223
- Sponsor's protocol ID
- QUMS 1234
- Status last verified
- Sep 2010
- First submitted
- 23 Aug 2010
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
- ClinicalTrials.gov ID
- NCT01198223
- Acronym / sponsor ID
- QUMS 1234
- Conditions
- Denture Stomatitis
- Keywords
- denture stomatitis, nystatin, garlic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug: garlic extract, nystatin | Other | Drug: garlic , nystatinDrug: 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 . |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40 years of age and older
- confirm of denture stomatitis by the oral medicine specialists
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| garlic , nystatinAlso: aquous garlicmouthwash | Drug | drug: garlic extract, nystatin |
Primary outcome
reduction of diameter of erythematous lesion under denture
Time frame: first week
measuring erythematous lesion by visual and then photography and a colis
1 secondary outcome
complete relief of erythematous lesions
Time frame: fourth week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2010.
Related trials for Denture Stomatitis
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mahin bakhshi, DDS,MS study chair
Qazvin University of Medical Science
Jamileh bigom Taheri, DDS/MS study director
Shahid Beheshti University of Medical Science
Samira Basir Shabestari, DDS/MS principal investigator
QUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing garlic , nystatin in people with Denture Stomatitis, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of diameter of erythematous lesion under denture (time frame: first week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2010.