Determining the effect of Propolis mouthwash on denture stomatitis treatment
Design
This study is a randomized, double blind, parallel group clinical trial with control group.
Settings and conduct
This study is performed on sixty 40-80-year-old patients among persons referred to the Semnan dental school who have lesions due to denture stomatitis. The patients are randomly divided into two groups of thirty patients in each group. In case and control group, the Propolis and Placebo mouthwash, are given respectively, to gargle a dose three times in a day, 3-5 minutes in each turn, and continue until ten days. Accordingly, the patient and the person who performs the clinical examination are not aware of the type of mouthwash. Then, on the first, fifth and tenth day after the beginning of the study, samples are examined for the severity of the lesions through clinical examination.
Participants/Inclusion and exclusion criteria
80-40 year old patients who are attended Semnan dental school and have denture stomatitis.
Intervention groups
Sixty patients are randomly divided into two case and control groups. In the case group, Propolis mouthwash (Mashhad Soren Tak Toos, with 30% extraction) and for control group distilled water plus authorized additives as Placebo (from Co. as mentioned earlier) with similar characteristics in color, odor, condition and bottles are given to the patients.
Main outcome variables
Treatment of fungal lesions caused by denture stomatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170828035942N2
Registration date:2018-03-05, 1396/12/14
Registration timing:registered_while_recruiting
Last update:2018-03-05, 1396/12/14
Update count:0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
maryam jalili sadrabad
Name of organization / entity
semnan university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 23 3333 4657
Email address
maryam.jalili@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Semnan University of Medical Sciences.
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Propolis Mouthwash and Placebo Effect on Denture Stomatitis Treatment in Denture Wearers -A Clinical Trial Study.
Public title
Propolis Effect on Denture Stomatitis Treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40-80 years old
Patients with Denture Stomatitis lesions
Exclusion criteria:
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty patients are randomly divided into two groups in the present research, consist of thirty case and control people. The randomizing process is done by using the random numbered bottles, according to a random numbers table. Therefore, the patient and the person who performs the clinical examination doesn't know the type of mouthwash.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the patient, the person who gives the drug to the patient, the investigators and administrators, the person who examines the patient about the effect of the drug, the person who performs the statistical analysis, and observer are not aware of type of drugs (Propolis or placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Vice chancellor for research, Setad Building, Basij blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.SEMUMS.REC.1396.57
2
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Vice chancellor for research, Setad Building, Basij blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ir.semums.rec.1396.57
Health conditions studied
1
Description of health condition studied
denture stomatitis
ICD-10 code
B37.0
ICD-10 code description
candidal stomatitis
Primary outcomes
1
Description
Clinical improvement of infection
Timepoint
day 1, 5 and 10 after intervention
Method of measurement
clinical scoring
Secondary outcomes
1
Description
no need
Timepoint
no need
Method of measurement
no need
Intervention groups
1
Description
Intervention group: Propolis mouthwash with 30% extraction, which is produced by Mashhad Tak Toos Soren Co. is employed in this investigation. An instructor firstly explained for the patients how to use the drug; that is, a dose of it must be gargled 3-5 minutes in each turn, three times a day and continue until 10 days. Then, on the first, fifth and tenth days after beginning the study, the samples are examined for the severity of the lesions in the mouth and information is recorded.
Category
Treatment - Drugs
2
Description
To fulfill the objectives of this research, a Placebo mouthwash is utilized which is prepared from the company mentioned above (distilled water and admixtures), with similar characteristics in color, odor, condition and bottles. An instructor firstly explained for the patients how to use the drug; that is, a dose of it must be gargled 3-5 minutes in each turn, three times a day and continue until 10 days. Then, on the first, fifth and tenth days after beginning the study, the samples are examined for the severity of the lesions in the mouth and information is recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Dental School
Full name of responsible person
Maryam Jalili Sadrabad
Street address
Faculty of Dentistry, Semnan University of Medical Sciences, Hefdah Shahrivar St., Saadi Square
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Email
Maryam.jalili@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of Semnan Dental School
Full name of responsible person
Dr. Nazila Ameli
Street address
Research Renter,Semnan dental school,17 Shahrivar Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Email
Maryam.jalili@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of Semnan Dental School
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
Semnan University of Medical Sciences
Full name of responsible person
Dr. maryam jalili sadrabad
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Semnan Dental School.Oral Medicine Department
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Fax
Email
dr.njalili@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Maryam Jalili Sadrabad
Position
Oral medicine
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral Medicine Department, Semnan Dental School, Hefdah Shahrivar blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Fax
Email
dr.njalili@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Maryam Jalili
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Semnan University of Medical Sciences, Hefdah Shahrivar Blvd, Saadi Square
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Fax
Email
Maryam.jalili@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available