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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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History
# Registration date Revision Id
3 2025-01-10, 1403/10/21 327322
2 2022-03-09, 1400/12/18 219540
1 2022-03-07, 1400/12/16 219341
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  • General information

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    84
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    2023-05-01, 1402/02/11
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    2023-08-20, 1402/05/29
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    2023-09-20, 1402/06/29

  • Health conditions studied

    #1
    K02
    Dental caries
    Dental caries
    salivary levels of IgA and pH
    پوسیدگی دندان
    میزان IgA و pH بزاق

  • Sponsors / Funding sources

    #1
    empty
    0054

Protocol summary

Study aim
Determining the effect of daily use of post-biotic toothpaste on salivary IgA in children 6 to 12 years old
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Salivary IgA level measured by ELISA kit; Saliva pH measured by pH indicator strips

General information

Reason for update
In the intervention groups section, the name of the microorganism that will be used in the toothpaste was mistakenly written wrong.
Acronym
IRCT registration information
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
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
Samaneh Khanehmasjedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 9516
Email address
khanehmasjedi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
2023-05-01, 1402/02/11
Actual recruitment end date
2023-08-20, 1402/05/29
Trial completion date
2023-09-20, 1402/06/29
Scientific title
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
Public title
Postbiotics and salivary IgA
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Actual sample size reached: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to study groups will be done using random block method and using 6 blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, the person evaluating the result of the intervention, and data analyzer have no information regarding the type of the participants’ treatment.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Deputy of research and technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-03-05, 1400/12/14
Ethics committee reference number
IR.AJUMS.REC.1400.676

Health conditions studied

1

Description of health condition studied
salivary levels of IgA and pH
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Salivary IgA level
Timepoint
before intervention and 30 days after intervention
Method of measurement
Saliva collection and IgA measurement by ELISA kit

Secondary outcomes

1

Description
Salivary pH
Timepoint
before intervention and 30 days after intervention
Method of measurement
pH indicator strips

Intervention groups

1

Description
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.
Category
Prevention

2

Description
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.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of pediatric dentistry, School of dentistry
Full name of responsible person
Leila Basir
Street address
School of dentistry, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3320 5169
Email
dental_research@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoush Zaker-kish
Street address
1st floor, School of public health, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8392
Email
jitdrc@yahoo.com
Grant name
Grant code / Reference number
0054
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Khanehmasjedi
Position
research assistant
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Fax
Email
masjedi.samaneh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Khanehmasjedi
Position
research assistant
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Fax
Email
masjedi.samaneh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Khanehmasjedi
Position
research assistant
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Fax
Email
masjedi.samaneh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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