Comparison of the effect of ginger mouthwash and nystatin suspension in the treatment of denture stomatitis
Design
The third phase of the clinical trial, two groups of parallel, each group of 25, were double blinded, randomized
Settings and conduct
This study is performed on 50 patients at the Faculty of Dentistry, Islamic Azad University, Tehran Branch of Oral and Maxillofacial Disease. After obtaining informed written consent, the patient is asked about the duration of the use of denture, the manner and frequency of cleaning , and whether or not use denture at night. In order to evaluate the patient's objective symptoms, the area of a region is more specific and widespread than erythema. First, it is done by marking it with a pencil and then measured by a calibrated paper in mm2. Measures are used in this study is the "Vi-one" ginger mouthwash And the 100000 UI Nystatin suspension that will be poured into the bottles by the pharmacist and the only difference will be in the numbers that will be inserted as code on them. double blind study is done on 50 patients. Each patient is required to use 5 ml of the drug 4 times a day for 5 minutes each time for 2 minutes as a mouthwash and refrain from eating and drinking for 30 minutes. Erythromatic areas on the first day before starting the drug and days 21,14,7 is measured by the researcher after starting the drug.
Participants/Inclusion and exclusion criteria
Entry requirements: patients with denture stomatitis.
Non entry requirements: Diabetes, xerostomia, immune system weakened due to chemotherapy and radiotherapy, use antibiotics and antifungals over the past 4 weeks.
Intervention groups
Ginger Mouthwash Group and Nystatin Suspension Group
Main outcome variables
Area of erythema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190506043489N1
Registration date:2020-01-06, 1398/10/16
Registration timing:registered_while_recruiting
Last update:2020-01-06, 1398/10/16
Update count:0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Kiarash Farzan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2642 4970
Email address
kiarash.farzan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Effect of Ginger Mouthwash and Nystatin Suspension in Patients with Denture Stomatitis
Public title
Effect of Ginger Mouthwash in treatment of Denture Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients referred with Denture Stomatitis
Exclusion criteria:
Diabetes
Xerostomia
Hypoparathyroidism
Immune system changes
Radiotherapy
Chemotherapy
Use of antibiotics and antifungals over the past four weeks
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The mouthwashes are poured into identical bottles, then numbered in random order, and by simple randomization, using the calculator, we obtain random numbers for the patient and give mouthwash to the patient .
Blinding (investigator's opinion)
Double blinded
Blinding description
Ginger mouthwash and nystatin suspension are spilled by the pharmacist in one shape, one color and one size bottles, and their only difference is in the number that will be entered as the code. The study is double blind and researcher and patients do not know the medication content of the bottle.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Medical Sciences, Tehran, Iran
Street address
No. 9, 9th Neyestan Ave., Pasdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
ir.iau.dental.rec.1398.007
Health conditions studied
1
Description of health condition studied
denture stomatitis
ICD-10 code
K12.1
ICD-10 code description
Other forms of stomatitis
Primary outcomes
1
Description
Area of erythema in denture stomatitis
Timepoint
Before the intervention and 7,14,21 days after the intervention
Method of measurement
Calibrated paper (transparent paper graded to 5 mm squares)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients gargle Vi-One Ginger Mouthwash with 25% zingiber extract, for 21 days, every 6 hours, each time use 15 ml for one minute.
Category
Treatment - Drugs
2
Description
Control group: Patients gargle Emad 100,000 UI nystatin suspensions, for 21 days, every 6 hours, each time use 15 ml for one minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry Islamic Azad University, Tehran Branch Oral and Maxillofacial Diseases Departme
Full name of responsible person
Somayeh Alirezaei
Street address
No. 9, 9th Neyestan Ave., Pasdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
Dr.somayehalirezaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kiarash Farzan
Street address
No 9, 9th Neyestan Ave., Pasdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kiarash.farzan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kiarash Farzan
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan Ave., Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2642 4970
Email
kiarash.farzan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Alirezaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan Ave., Pasdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Dr.somayehalirezaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kiarash Farzan
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan Ave., Pasdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2642 4970
Email
kiarash.farzan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, the results are shared with patients' confidentiality.
When the data will become available and for how long
The access period begins in 2020 after the results are published as a thesis.
To whom data/document is available
Access to data is subject to the confidentiality of patients' personal information, only to researchers at academic centers.
Under which criteria data/document could be used
After publishing this study, access to the article is granted and there is no condition for its use.
From where data/document is obtainable
Applicants can apply for the document at www.jrds.ir.
What processes are involved for a request to access data/document
After being published on www.jrds.ir, the documentary is made available to applicants by searching at this website.