Objectives: In this study the untifungal effect of Green tea mouthwash 0.5% on patients with denture stomatitis was examined.
Design: Twenty two patients with denture stomatitis who had been referred to the department of oral medicine in sari faculty of dentistry in spring 1396 were divided into two groups.
Setting and conduct: One group received treatment with green tea mouthwash 0.5% four times a day and each time use 15 milliliter about 2.5 table spoon for two weeks. Another group use nystatin suspension 100000 u/l four times a day and each time use 1 milliliter about 20 drops for two weeks.
Participants including majoreligibility criteria: Absence of using denture in sleeping; No use of untifungal drugs and antibiotics and corticosteroid in past 1 month; No allergy to nystatin suspension; Absence of immunodeficiency; Absence of alzheimer; Absence of cyhalological disorders; Absence of musculoskeletal disorders; Ability to consume mouthwash.
Main outcome messures: First examination is before treatment is run to check the length and the width of lesions.7 days after first examination, in the second examination length and width are written.14 days after first examination, in the third examination length and width are written again.the microbial culture is done before treatment and after 14 days. Finally the data of two groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060334314N1
Registration date:2017-07-12, 1396/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Ashena Sadrzadeh
Name of organization / entity
Mazandaran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4225 1888
Email address
m.babaei@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2017-06-26, 1396/04/05
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of green tea mouthwash and nystatin suspension in denture stomatitis
Public title
comparison of therapeutic effect of green tea mouthwash in the treatment of stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Absence of using denture in sleeping; No use of untifungal drugs and antibiotics and corticosteroid in past 1 month; No allergy to nystatin suspension; Absence of immunodeficiency; Absence of alzheimer; Absence of cyhalological disorders; Absence of musculoskeletal disorders; Ability to consume mouthwash
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The number of sampling is chosen by convenient sampling. After that, by random sampling, one group of samples are located in the first intervention group, another group of samples in the second intervention group. Each individual is assigned a number and then randomly chosen so the objectivity of the research is reached.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran university of medical science, The martyr Motahhari square, Street teacher
City
Sari
Postal code
48157-3391
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.MAZUM.REC.96.2948
Health conditions studied
1
Description of health condition studied
denture stomatitis
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis Oral thrush
Primary outcomes
1
Description
length and width of lesions
Timepoint
Before intervention, one week after the beginning of intervention, two weeks after the beginnig of intervention
Method of measurement
calliper _ cm
2
Description
colonies number
Timepoint
Before intervention, two weeks after the beginnig of intervention
Method of measurement
Number of fungi
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group use the green tea mouthwash 0.5% 4 times a day each time 15 milliliter about two and half table spoon. They should use it after washing their mouth and use it for one minute in their mouth. They should refrain from eating and drinking for about one hour. It should be used for two weeks.
Category
Treatment - Drugs
2
Description
The second intervention group use the nystatin suspension 1000000 u/l four times a day and each time use one milliliter about 20 drops. They should use it after washing their mouth and use it for one minute in their mouth. They should refrain from eating and drinking for about one hour. It should be used for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic, Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Anahita Ghorbani
Street address
Dental clinic, Khazar Blvd, Khazar square Sari Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor for research, The martyr Motahhari square, Street teacher
City
Sari
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, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Anahita Ghorbani
Position
Professor / Associate Professor, School of Dentistry
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3330 2908
Fax
Email
Anahita1802@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Anahita Ghorbani
Position
Professor / Associate Professor, School of Dentistry
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3330 2908
Fax
Email
Anahita1802@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Anahita Ghorbani
Position
Professor / Associate Professor, School of Dentistry
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3330 2908
Fax
Email
Aghorbani@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)