A survey efficacy of Terminalia chebula and Commiphora opobalsamum oral mouth wash on denture stomatitis
Design
The clinical trial has a control group, with parallel, double-blind, randomized groups
Settings and conduct
This research is a double-blind clinical trial, which was performed on 50 patients with a denture stomatitis (this number of patients were selected based on previous studies and without the sample size formula). After clinical examination and confirmation of the type 2 disease and fill consent form, patients are included in the research. At the beginning, demographic information about age, gender, duration of use of the denture in time of sleep, the denture cleaning method and record the number of times cleaning. The patients were randomly divided into two groups of treatment 1) Herbal mouthwash containing Halileh and belsan.2) Mouthwash with Protact.
Participants/Inclusion and exclusion criteria
This research is a double blind clinical trial, which was performed on 50 patients with a steomatitis (this number of patients based on previous studies and without formulas of sample size). Patients who have a history of using antifungal, antibiotic and corticosteroid drugs in a recent month or are diagnosed with immunopressing disease, as well as those who are allergic to Halileh and, and protact mouthwash, have rodent muscles and cannot be used to turn mouthwash in the mouth from the study removed.
Intervention groups
The study consisted of two groups of control and drug recipient.The intervention group received the drug-containing mouthwash and the control group received the Protact Mouth wash.
Main outcome variables
Diameter of erythema
Recovery time
Herbal mouthwash containing halile and Belsan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130911014630N8
Registration date:2019-12-22, 1398/10/01
Registration timing:retrospective
Last update:2019-12-22, 1398/10/01
Update count:0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Mohammad Azadbakht
Name of organization / entity
Mazandaran University of Medical Scinecee
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3728
Email address
mazadbakht@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-10, 1398/08/19
Expected recruitment end date
2019-12-10, 1398/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey efficacy of Terminalia chebula and Commiphora opobalsamum oral mouth wash on denture stomatitis
Public title
A survey efficacy of Terminalia chebula and Commiphora opobalsamum oral mouth wash on denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with denture stomatitis
Exclusion criteria:
Patients who have a history of using antifungal, antibiotic and corticosteroid drugs, and immunosupress drugs in a recent month
patient are infected with immunosuppression disease
who are allergic to Halileh or protact mouthwash
patient who have Alzheimer's, disorders Rodent muscles and cannot rotate the mouthwash in the mouth are eliminated from the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The mouthwash is given in containers similar to the size, taste and smell of the patients
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher, patient, and specialist physician are unaware of the type of product.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciense research ethics committee
Street address
Darya Street
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2019-05-09, 1398/02/19
Ethics committee reference number
ir.mazums.rec.1398.1387
Health conditions studied
1
Description of health condition studied
denture stomatitis
ICD-10 code
K12
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
diameter of erythema
Timepoint
end of the first and second week
Method of measurement
diameter of erythema by caliper
Secondary outcomes
1
Description
recovery duration
Timepoint
first and second week
Method of measurement
The duration of the improvements in erythema diameter by caliper
Intervention groups
1
Description
Control group: Patients are asked to gargle 20 drops of Protact 2 times a day (morning and afternoon) and refrain from eating and drinking for half an hour. Do not use denture during sleep and place it in a 10: 1 ratio of water and vinegar.
Category
Prevention
2
Description
Intervention group: Patients are asked to gargle 20 drops of mouthwash twice a day (morning and afternoon) and refrain from eating and drinking for half an hour. Do not use it during sleep and place it in a container of water and vinegar at a ratio of 10 to 1 and replace your denture. The erythematous area is examined at the end of the first and second weeks and recovery is recorded in the form of denture stomatitis (type 2 to 1 conversion or complete remission).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuoshirvani Geriatric Center
Full name of responsible person
Dr Mohamad Azadbakht
Street address
Hamzekola
City
Babol
Province
Mazandaran
Postal code
4664117886
Phone
+98 11 3230 3298
Email
mazadbakht@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Emran Habibi
Street address
Darya street
City
Babol
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3044 0001
Email
publicrel@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
70
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohamad Azadbakht
Position
Professor of University
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Darya street
City
Sari
Province
Mazandaran
Postal code
4664117886
Phone
+98 11 3230 3298
Email
mazadbakht@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohamad Azadbakht
Position
Professor of univarsity
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Darya street
City
Sari
Province
Mazandaran
Postal code
4664117886
Phone
+98 11 3230 3298
Email
mazadbakht@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Mirdar Mansouri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Pharmacy
Street address
Farabi 16
City
Babol
Province
Mazandaran
Postal code
4664117886
Phone
+98 11 3230 3298
Email
m_mmansouri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Respecting patients privacy
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Because of patient privacy, their information is kept confidential, but the method of study and statistical data are coded to be published
When the data will become available and for how long
one year
To whom data/document is available
Advisor and researcher Supervisor
Under which criteria data/document could be used
If you expand the study and allow teachers to help
From where data/document is obtainable
Professor of University
What processes are involved for a request to access data/document