Protocol summary
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Study aim
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Determining the effect of daily use of post-biotic toothpaste on salivary IgA in children 6 to 12 years old
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Design
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Institutional-based, parallel groups, triple-blind, randomized clinical trial. Assignment of patients to study groups will be done using the random block method and using 6 blocks.
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Settings and conduct
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The research site will be the School of Dentistry of the Ahvaz Jundshapur University of Medical Sciences. Sampling will be performed by the non-probability method. Outcomes are measured before the intervention. Participants will be randomly divided into intervention and control groups and after the intervention, the outcomes will be measured again.
In this study, participants, the person evaluating the results and analyzer of the data will be blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: systemically healthy 6- to 12-year-old children with a mixed dental system
Exclusion criteria: the presence of inflammatory disease and use of antibiotics and probiotic products
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Intervention groups
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Intervention group: Children in this group brush their teeth twice a day for 30 days, using postbiotic toothpaste.
Control group: Children in this group brush their teeth twice a day for 30 days, using toothpaste similar to the intervention group. The only difference between the toothpaste used by this group is the lack of postbiotic.
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Main outcome variables
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Salivary IgA level measured by ELISA kit; Saliva pH measured by pH indicator strips
General information
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Reason for update
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In the intervention groups section, the name of the microorganism that will be used in the toothpaste was mistakenly written wrong.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191016045128N2
Registration date:
2022-03-07, 1400/12/16
Registration timing:
prospective
Last update:
2025-01-17, 1403/10/28
Update count:
2
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Registration date
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2022-03-07, 1400/12/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-04-21, 1401/02/01
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Expected recruitment end date
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2022-06-22, 1401/04/01
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Actual recruitment start date
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2023-05-01, 1402/02/11
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Actual recruitment end date
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2023-08-20, 1402/05/29
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Trial completion date
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2023-09-20, 1402/06/29
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Scientific title
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evaluation of the effect of daily usage of postbiotic toothpaste on salivary IgA levels in 6- to 12-year-old children: a triple-blind randomized controlled trial
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Public title
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Postbiotics and salivary IgA
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
6- to 12-year-old children
In mixed dentition
No systemic disease
Exclusion criteria:
Any presence of inflammatory diseases
Usage of antibiotics or probiotics within the 2 weeks before start of the study or through it
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Age
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From 6 years old to 12 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
80
Actual sample size reached:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Assignment of patients to study groups will be done using random block method and using 6 blocks.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The participants, the person evaluating the result of the intervention, and data analyzer have no information regarding the type of the participants’ treatment.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-03-05, 1400/12/14
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Ethics committee reference number
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IR.AJUMS.REC.1400.676
Health conditions studied
1
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Description of health condition studied
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salivary levels of IgA and pH
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Salivary IgA level
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Timepoint
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before intervention and 30 days after intervention
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Method of measurement
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Saliva collection and IgA measurement by ELISA kit
Secondary outcomes
1
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Description
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Salivary pH
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Timepoint
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before intervention and 30 days after intervention
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Method of measurement
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pH indicator strips
Intervention groups
1
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Description
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Intervention group: Children in this group brush their teeth twice a day for 30 days, using toothpaste containing post-biotic Bifidobacterium animalis subsp. animalis with a concentration of 2*10^ 9.
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Category
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Prevention
2
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Description
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Control group: Children in this group brush their teeth twice a day for 30 days, using toothpaste similar to the intervention group. The only difference between the toothpaste used by this group is the lack of post-biotic.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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0054
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available