Investigation of herbal toothpaste containing Salvadora persica, Prpolis and Stevia rebaudiana on group of Streptococcus mutans bacteria and its comparison whith a common chemichal toothpaste.
Comparison of plant toothpaste containing Salvadora persica extract, Propolis and Stevia rebauiana with a common chemical toothpaste on the amount of bacteria in Streptococcus mutans saliva
Design
Clinical trial with two groups including chemical or herbal toothpaste, with parallel groups, 70 patients
Settings and conduct
In this clinical trial study, we first perform scaling and health education for all participants, who are 70 in Qom Dental School. After preparing a non-stimulated saliva sample from all participants, we randomly divide the participants into two groups of 35 people. Participants used toothpaste for 14 days, after which a saliva sample was taken to test for Streptococcus mutans. Finally, the number of colonies of Streptococcus mutans in saliva for both groups of toothpaste will be examined by Mann-U-Whitney and Wilcoxon tests.
Participants/Inclusion and exclusion criteria
Participants in the study should have normal periodontium and no systemic disease or a history of antibiotics, anti-inflammatory drugs, and periodontal treatment during the past 3 months.
Candidates must be 18 years of age or older and must have at least 20 teeth.
People who are definitely allergic to the herbal ingredients in toothpaste.
People with orthodontic appliances or fixed or removable prostheses will be excluded from smoking, pregnant and lactating women.
Intervention groups
Group 1: Prophylaxis and scaling and preparation of saliva sample and use of herbal toothpaste for two weeks and then re-preparation of saliva sample
Group 2: Prophylaxis and scaling and preparation of saliva sample and use of chemical toothpaste for two weeks and then re-preparation of saliva sample
Main outcome variables
Age , Gender , Salivary bacteria , Toothpaste
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210604051492N1
Registration date:2021-07-08, 1400/04/17
Registration timing:registered_while_recruiting
Last update:2021-07-08, 1400/04/17
Update count:0
Registration date
2021-07-08, 1400/04/17
Registrant information
Name
seyed mohammad amin Motevallia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3770 0094
Email address
aminmotevallia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of herbal toothpaste containing Salvadora persica, Prpolis and Stevia rebaudiana on group of Streptococcus mutans bacteria and its comparison whith a common chemichal toothpaste.
Public title
Effect of herbal toothpaste containing Salvadora persica, Prpolis and Stevia rebaudiana on group of Streptococcus mutans bacteria
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Have normal periodontium
Have no systemic illness or history of antibiotics, anti-inflammatory drugs and periodontal treatment in the past 3 months
Have at least 20 teeth
People who are definitely allergic to the herbal ingredients in toothpaste.
Exclusion criteria:
Smoker people
Pregnant people
Brestfeeding people
People have fixed or removable orthodontics and dental Prosthesis applience
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
2
Saliva samples are prepared from each person at the beginning and end of the study
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Dentistry faculty of Qom university of medical science saheli ave, bajak blvd
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.MUQ.REC.1400.033
Health conditions studied
1
Description of health condition studied
The amount of bacteria in the group of Streptococcus mutans saliva
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of bacteria in the group of Streptococcus mutans saliva
Timepoint
At the beginning of the study and day 14 after consuming toothpaste.
Method of measurement
The number of colonies formed in each plate is calculated by CFU method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Herbal toothpaste, twice a day for 14 days , Albodent herbal toothpaste factory of Armaghan Salamat Alvand Faraz Company
Category
Prevention
2
Description
Intervention group: Chemical toothpaste, used twice a day for two weeks, use a common type of chemical toothpaste produced in Iran that has a standard
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom faculty of Dentistry, Medical Sciences
Full name of responsible person
Dr. Mehrdad Kahvand
Street address
Qom faculty of Dentistry, Saheli ave, Bajak blvd
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0094
Email
aminmotevallia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Ayda Mehdipour
Street address
Qom faculty of Dentistry, Saheli ave, Bajak blvd
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0094
Email
info@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
10
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
Ghoum University of Medical Sciences
Full name of responsible person
Seyed Mohammad Amin Motevallia
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qom School of Dentistry,Saheli ave, Bajak blvd
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 9770 0094
Email
aminmotevallia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Merdad Kahvand
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qom School of Dentistry, Saheli ave, Bajak blvd
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0094
Email
aminmotevallia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyed Mohammad Amin Motevallia
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qom School of Dentistry, Saheli ave, Bajak blvd
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0094
Email
aminmotevalllia@gmail.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Start access to data September 1400
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The information obtained from this study is only permissible to evaluate the effectiveness of the components of herbal toothpaste on the amount of saliva bacteria available to individuals.
From where data/document is obtainable
Saheli St., Qom Dental School, Vice Chancellor for Research
Phone: 02537700094
What processes are involved for a request to access data/document
Request to the Vice Chancellor for Research of the School of Dentistry and then receive within a week
Comments
It should be noted that the data obtained from this study have no commercial benefit