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Investigating the effect of daily consumption of probiotic milk and normal milk on the rate of caries of primary teeth (dmft) buffer status, pH, and the amount of Streptococcus mutans in the saliva of 3-6 years old children. A clinical trial

Protocol summary

Study aim
The effect of daily consumption of probiotic and regular milk on the rate of dental caries and Streptococcus mutans, and the buffering status and pH in children's saliva
Design
A phase 3 clinical trial that is randomized. 24 patients will be randomly assigned to two intervention and control groups.
Settings and conduct
This study will be conducted to investigate the preventive effects of prebiotic products on dental caries in children in Zanjan. children will be randomly assigned to two intervention and control groups. In the control group, they will receive non-probiotic milk, in the intervention group, a package containing probiotic powder along with milk. Saliva samples and caries index of the subjects will be measured at the beginning, 3, 6, and 12 months after the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy children who consume milk daily, without a history of systemic diseases or allergic reactions, availability to participate in the 6-month follow-up, consent to participate in the study. Exclusion criteria: Patients with a history of severe medical illness or allergic reactions, people who consume more or less than the recommended amount of milk.
Intervention groups
The intervention group includes children whose parents breastfeed them according to the minister's instructions. Parents will be instructed to prepare the milk as follows: A quarter teaspoon of probiotic powder from the L. paracasei SD1 probiotic sachet (fssai, KAN phytochemicalsal Pvt, India) will be added to 200 ml of milk (200 ml milks available in the market will be selected) to obtain a final concentration of 107 CFU/mL for each use in the probiotic group. Due to ethical considerations, it is not possible to add another powder as a placebo in the control group.
Main outcome variables
caries index(dmft), pH level, Streptococcus mutans bacteria

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210718051926N2
Registration date: 2025-07-28, 1404/05/06
Registration timing: registered_while_recruiting

Last update: 2025-07-28, 1404/05/06
Update count: 0
Registration date
2025-07-28, 1404/05/06
Registrant information
Name
bahareh nazemi salman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3341 2597
Email address
dr.b.nazemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of daily consumption of probiotic milk and normal milk on the rate of caries of primary teeth (dmft) buffer status, pH, and the amount of Streptococcus mutans in the saliva of 3-6 years old children. A clinical trial
Public title
effect of daily consumption of probiotic milk and normal milk on the rate of caries of primary teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy children who drink milk daily, No history of systemic diseases or allergic reactions Availability to participate in the 6-month follow-up, Consent to participate in the study
Exclusion criteria:
Patients with a history of severe medical illness or allergic reaction People who consume more or less than the recommended amount of milk.
Age
From 3 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Children will be randomly assigned to two intervention and control groups. The method of assigning children to the two groups will be as follows: after meeting the study entry criteria, a number will be randomly generated by the Random Generator software (available online). If the number obtained is even, the child will be assigned to the intervention group, and if it is odd, the child will be assigned to the control group.
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 Zanjan University of Medical Sciences
Street address
mahdavi street
City
zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2025-03-04, 1403/12/14
Ethics committee reference number
IR.ZUMS.REC.1403.327

Health conditions studied

1

Description of health condition studied
k00
ICD-10 code
k00
ICD-10 code description
tooth

Primary outcomes

1

Description
caries of primary teeth
Timepoint
Start of the study - Three months after the study - Six months after the study - Twelve months after the study
Method of measurement
DMFT decay index, which indicates the status of decayed teeth, teeth extracted due to decay, and teeth filled due to decay.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:One-fourth tablespoon of probiotic powder from the L. paracasei SD1 probiotic sachet (fssai, KAN phytochemicals Pvt, India) will be added to 200 mL of milk (200 mL milks available in the market will be selected) to obtain a final concentration of 107 CFU/mL for each administration in the probiotic group.
Category
Other

2

Description
Control group: Children who will only receive regular milk(Routine milk powder).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabesam Children's Dental Clinic
Full name of responsible person
dr Bahareh Nazemi Salman
Street address
safa street
City
zanjan
Province
Zanjan
Postal code
45144456321
Phone
+98 912 377 7185
Email
dr.b.nazemi@gmail.com
Web page address
https://medicalnet.ir/Clinic/Type/View/ID/2397/%DA%A9%D9%84%DB%8C%D9%86%DB%8C%DA%A9-%D8%AA%D8%AE%D8%B5%D8%B5%DB%8C-%D8%AF%D9%86%D8%AF%D8%A7%D9%86%D9%BE%D8%B2%D8%B4%DA%A9%DB%8C-%D8%AA%D8%A8%D8%B3%D9%85

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
bahareh nazemi salman
Street address
mahdavi street
City
zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 377 7185
Email
dr.b.nazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
bahareh nazemi salman
Position
associated proffesor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
mahdavi street
City
zanjan
Province
Zanjan
Postal code
4514446967
Phone
+98 919 143 9740
Email
dr.b.nazemi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
bahareh nazemi salman
Position
associated proffesor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
mahdavi street
City
zanjan
Province
Zanjan
Postal code
4514446967
Phone
+98 919 143 9740
Email
dr.b.nazemi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
bahareh nazemi salman
Position
associated proffesor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
mahdavi street
City
zanajn
Province
Zanjan
Postal code
4514446967
Phone
+98 919 143 9740
Email
dr.b.nazemi@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
For those interested in research and those who plan to continue this research topic, the information they need will be sent to them after they submit their request. All data that will be entered into SPSS software can be shared after removing the names of the individuals.
When the data will become available and for how long
After the article is published and all information and analysis are extracted, it will be stated in the article that the responsible author will send the information to those interested if they receive an email.
To whom data/document is available
People interested in the results of this research topic in industry and academia
Under which criteria data/document could be used
There will be no restrictions on performing various analyses on this data.Email of the corresponding author that will be mentioned in the article dr Bahareh Nazemi Salman dr.b.nazemi@gmail.com
From where data/document is obtainable
Email of the corresponding author that will be mentioned in the article dr Bahareh Nazemi Salman dr.b.nazemi@gmail.com
What processes are involved for a request to access data/document
After receiving the email, the responsible author will make the necessary correspondence and send the file if necessary. Email of the corresponding author that will be mentioned in the article dr Bahareh Nazemi Salman dr.b.nazemi@gmail.com
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