The purpose of current study is to evaluate the effects of ginger mouthwash on treatment of denture stomatitis (DS).
This is a randomized double-blind clinical trial and 25 patients were included in each group.
The subjects were randomly assigned to receive ginger mouthwash (group I) or nystatin mouthwash (group II). Two groups were similar regarding the grade of DS. Group I were instructed to rinse their mouth with 5 ml of ginger mouthwash 2%, while group II used 100000 of nystatin mouthwash . Both groups used mouthwash 3 times a day for 15 days. The patients were advised to swish mouthwash for 3 minute and avoid eating and drinking for 30 minutes afterwards. Ginger and nystatin mouthwash bottles were in an identical shape and the patients or the researcher evaluating the outcomes were unaware of the drug inside the bottles.
Inclusion criteria: denture stomatitis.
Exclusion criteria: history of taking corticosteroids, antibiotics , antifungals or immunosuppressive during last month, having immunosuppression illness, history of allergic reaction to ginger or nystatin, Alzheimer's disease or masticatory muscles disorder
Assessment of erythematous lesions was performed at the end of first and second week. A fungul culture was prepared from palate at the end of first session and also at final session. The patients’ satisfaction degree of using either ginger or nystatin mouthwashes were documented as very good, good, relatively good, poor and very poor.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016060818479N2
Registration date:2016-07-17, 1395/04/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-17, 1395/04/27
Registrant information
Name
Sohrab Kazemi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 4308
Email address
s.kazemi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Babol University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of comparison of ginger mouthwash and nystatin suspension on treatment of denture osteomatitis among denture patients
Public title
Efficacy of ginger mouthwash on treatment of denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: who has denture osteomatitis.
Exclusion criteria: history of taking corticosteroids, antibiotics, antifungals or immunosuppressive drugs during last month; having immunosuppressive illness; history of allergic reaction to ginger or nystatin; Alzheimer disease or masticatory muscles disorders
Age
From 25 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were allocated to intervention and control groups using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafroz Street, Daneshgah Square, Babol University of Medical Sciences
City
Babol
Postal code
4717641367
Approval date
2016-05-01, 1395/02/12
Ethics committee reference number
MUBABOL.REC.1395.7
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
Treatment duration
Timepoint
end of first and second week
Method of measurement
clinical change in erythematose zone
Secondary outcomes
1
Description
Number of colonies
Timepoint
First visit, end of second week
Method of measurement
culture preparing
Intervention groups
1
Description
Intervention group: ginger mouthwash 2%, 5 ml ,3 times a day, for 2 weeks
Category
Treatment - Drugs
2
Description
control group: nystatin mouthwash 100000 u/ml ,5 ml, 3 times a day, for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral medicine department, Babol School of Dentistry
Full name of responsible person
Zahra Allizadeh
Street address
Dental School, Babol University of Medical Sciences, Ganjafroz Street, Daneshgah Square
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Babol University of Medical Sciences
Full name of responsible person
Dr Aliakbar Moghadamnia
Street address
Ganjafroz Street, Daneshgah Square, Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Post graduate student
Other areas of specialty/work
Street address
Dental School, Babol University of Medical Sciences, Ganjafroz Street, Daneshgah Square
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
Alizadeh6281@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Neda Babaee
Position
Associate Professor
Other areas of specialty/work
Street address
Dental School, Babol University of Medical Sciences, Ganjafroz Street, Daneshgah Square
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
dr.neda babaee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Post graduate student
Other areas of specialty/work
Street address
Dental School, Babol University of Medical Sciences, Ganjafroz Street, Daneshgah Square
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
Alizadeh6281@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)