Comparsion of the antimicrobial effect of two toothpastes on salivary streptococcus mutans and lactobacillus and candida albicans of plaque in children aged 4 to 6 years with Early Chilhdood Caries
Comparsion of antimicrobial effect of aloe vera containing toothpaste and fluoride toothpaste on the amount of salivary Streptococcus mutans and Lactobacillus and Candida albicans of plaque in children 4 to 6 years old with ECC
Design
This study is a clinical trial with a control group on 26 patients, with cross-over design and double-blind, which is randomized by simple method.
Settings and conduct
The study is performed at the School of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Saliva and plaque sampling is done before using the first type of toothpaste in each group and one month after its consumption. After a waiting period of 2 weeks, two groups will use opposite toothpastes. Similar to the first period, sampling is done. Patients, microbiologists and statistics analyst are not aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Children 4 to 6 years old with ECC who have 2 to 3 decayed teeth and their parents are willing to participate in the study and who are positive or completely positive according to Frankel behavior scale.
Children without systemic disease who have no intraoral pathology.
Children who have not had a history of receiving professional topical fluoride as well as antibiotics in the past 3 months or during treatment.
Intervention groups
In order to evaluate the antimicrobial effect of two toothpastes, the samples were randomly assigned to receive aloe vera toothpaste at one stage in the study group and then fluoridated toothpaste at another stage in the control group.
Main outcome variables
Number of Streptococcus mutans; Lactobacillus and Candida albicans colonies cultured in culture medium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191004044977N2
Registration date:2020-12-18, 1399/09/28
Registration timing:prospective
Last update:2020-12-18, 1399/09/28
Update count:0
Registration date
2020-12-18, 1399/09/28
Registrant information
Name
Maedeh Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5351 6111
Email address
mrezaei2024@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of the antimicrobial effect of two toothpastes on salivary streptococcus mutans and lactobacillus and candida albicans of plaque in children aged 4 to 6 years with Early Chilhdood Caries
Public title
Antimicrobial effect of two toothpastes in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 4 to 6 years who have 2 to 3 decayed teeth
Children without systemic disease
Not receiving professional topical fluoride in the last 3 months
Absence of any intraoral pathology
Children who are positive or completely positive according to Frankel Behavior scale
Consent of parents and patients to participate in the study
Exclusion criteria:
Children who need emergency dental treatment
Children undergoing orthodontic treatment or with intraoral prostheses
Take antibiotics 3 months before treatment or during treatment
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
26
More than 1 sample in each individual
Number of samples in each individual:
4
According to receiving a sample from the patient before the delivery of the first type of toothpaste and one month after its consumption and also receiving the sample before the delivery of the second type of toothpaste and one month after its consumption, each patient has four samples.
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple and individual using a list of random numbers that includes two groups A and B. In group A, patients are given aloe vera toothpaste in the first phase and in group B, in the first phase, fluoride toothpaste is given to patients.
The listed numbers are written on the same paper and placed in the same envelope. The envelopes are opaque and do not have any mark or writing. All 26 envelopes are placed in a box, and after determining the adequacy of the sample to enter the study and obtain informed consent, the patient is asked to choose one of the envelopes in the box. The envelope is opened, the patient number and the type of intervention in the first phase are determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the uniform coverage of the toothpaste tubes, the patient is unaware of which treatment group she/he is in. Also, the microbiologist is unaware of which group the samples belong to.
The statistics analyst is not aware of type of intervention for each patient.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences یزد
Street address
Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
89148-15669
Approval date
2020-07-28, 1399/05/07
Ethics committee reference number
IR.SSU.REC.1399.100
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified
Primary outcomes
1
Description
Salivary Streptococcus mutans
Timepoint
At the beginning of the study and 30 days later
Method of measurement
Counting the number of Streptococcus mutans colonies in MSA culture medium
2
Description
Salivary lactobacillus
Timepoint
At the beginning of the study and 30 days later
Method of measurement
Counting the number of lactobacillus colonies in MRS culture medium
3
Description
Candida Albicans plaque
Timepoint
At the beginning of the study and 30 days later
Method of measurement
Counting the number of Candida albicans colonies in Sabouraud dextrose agar culture medium
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use aloe vera toothpaste (Forever Living Product, Scottsdale, AZ, USA) for thirty days. Then the wash out period for 2 weeks and displacement of control and case groups .
Category
Treatment - Other
2
Description
Control group: Use fluoride toothpaste (2080; Aekyung Industrial, Seol, Korea) for thirty days. Then the wash out period for 2 weeks and displacement of control and case groups .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Shahid Sadoughi
Full name of responsible person
Maedeh Rezaei
Street address
Dahe fajr Ave, Immam Reza Square, Shahid Sadoughi University
City
Yazd
Province
Yazd
Postal code
8914815669
Phone
+98 35 3621 4257
Email
mrezaei2024@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzae
Street address
Bahonar Square , Central Building of University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
masoud_mirzae@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd University of Medical Sciences
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
Yazd University of Medical Sciences
Full name of responsible person
Maedeh Rezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty of Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Dahe fajr Ave.
City
Yazd
Province
Yazd
Postal code
8914815669
Phone
+98 35 3621 4257
Email
mrezaei2024@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maedeh Rezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty of Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Dahe fajr Ave.
City
Yazd
Province
Yazd
Postal code
8914815669
Phone
+98 35 3621 4257
Email
mrezaei2024@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maedeh Rezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty of Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Dahe fajr Ave.
City
Yazd
Province
Yazd
Postal code
8914815669
Phone
+98 35 3621 4257
Email
mrezaei2024@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Undetectable information will be released, including age, sex and number of decayed teeth. The results of the study, including the number of bacterial and fungal colonies, will also be published.
When the data will become available and for how long
Starting 9 months after publication
To whom data/document is available
The data are only available for people working in academic institutions.
Under which criteria data/document could be used
Use of this data is permitted for systematic review and meta-analysis . Similar clinical trials can also use to criticiza the present study and its results in their discussion.
From where data/document is obtainable
Send an email to 1 : mrezaei2024@gmail.com 2: zbahrololoom@yahoo.com
What processes are involved for a request to access data/document
After the request via one of the two methods listed above, if the request matches the sharing information mentioned before, this information will be available to the applicant within one month.