Effect of postbiotic-toothpaste on salivary levels of IgA in 6- to 12-year-old children: Study protocol for a randomized triple-blind placebo-controlled trial
Children in mixed dentition are highly at risk for dental caries, which is a major health issue worldwide. Despite their effect in controlling dental caries, using probiotics can be challenging. Therefore, it has been advised to use their inanimate forms, called postbiotics. We hypothesize that post...
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| Published in | Frontiers in pediatrics Vol. 10; p. 1042973 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Switzerland
Frontiers Media S.A
12.12.2022
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| Abstract | Children in mixed dentition are highly at risk for dental caries, which is a major health issue worldwide. Despite their effect in controlling dental caries, using probiotics can be challenging. Therefore, it has been advised to use their inanimate forms, called postbiotics. We hypothesize that postbiotics can enhance the oral immunity.
The aim of this triple-blind, randomized, placebo-controlled trial is to investigate the effect of postbiotic-toothpaste (
) on salivary levels of Immunoglobulin A (IgA) and pH in children. Using comparing two means formula to calculate the sample size, for this trial 80 healthy 6- to 12-year-old children during mixed dentition with no cavitated dental caries will be selected by convenience sampling method and randomly allocated to two groups, postbiotic-toothpaste or placebo-toothpaste. Saliva samples will be gathered at baseline and four weeks after the intervention. The level of salivary IgA will be determined by ELISA and salivary pH will be measured using a pH meter. Data will be compared within and between groups using independent t-test and paired t-test, in case of normality, with a
< 0.05 as statistically significant.
If postbiotics-toothpaste prove to be effective in improving the oral immunity, they can be used to prevent dental caries and other oral diseases. The result of this study can help researchers who are working on the immunomodulatory effects of postbiotics in children.
Iranian Registry of Clinical Trials (IRCT), IRCT20191016045128N2. Registered on 7 March 2022. |
|---|---|
| AbstractList | Children in mixed dentition are highly at risk for dental caries, which is a major health issue worldwide. Despite their effect in controlling dental caries, using probiotics can be challenging. Therefore, it has been advised to use their inanimate forms, called postbiotics. We hypothesize that postbiotics can enhance the oral immunity.BackgroundChildren in mixed dentition are highly at risk for dental caries, which is a major health issue worldwide. Despite their effect in controlling dental caries, using probiotics can be challenging. Therefore, it has been advised to use their inanimate forms, called postbiotics. We hypothesize that postbiotics can enhance the oral immunity.The aim of this triple-blind, randomized, placebo-controlled trial is to investigate the effect of postbiotic-toothpaste (Bifidobacterium animalis subsp. animalis) on salivary levels of Immunoglobulin A (IgA) and pH in children. Using comparing two means formula to calculate the sample size, for this trial 80 healthy 6- to 12-year-old children during mixed dentition with no cavitated dental caries will be selected by convenience sampling method and randomly allocated to two groups, postbiotic-toothpaste or placebo-toothpaste. Saliva samples will be gathered at baseline and four weeks after the intervention. The level of salivary IgA will be determined by ELISA and salivary pH will be measured using a pH meter. Data will be compared within and between groups using independent t-test and paired t-test, in case of normality, with a p < 0.05 as statistically significant.MethodsThe aim of this triple-blind, randomized, placebo-controlled trial is to investigate the effect of postbiotic-toothpaste (Bifidobacterium animalis subsp. animalis) on salivary levels of Immunoglobulin A (IgA) and pH in children. Using comparing two means formula to calculate the sample size, for this trial 80 healthy 6- to 12-year-old children during mixed dentition with no cavitated dental caries will be selected by convenience sampling method and randomly allocated to two groups, postbiotic-toothpaste or placebo-toothpaste. Saliva samples will be gathered at baseline and four weeks after the intervention. The level of salivary IgA will be determined by ELISA and salivary pH will be measured using a pH meter. Data will be compared within and between groups using independent t-test and paired t-test, in case of normality, with a p < 0.05 as statistically significant.If postbiotics-toothpaste prove to be effective in improving the oral immunity, they can be used to prevent dental caries and other oral diseases. The result of this study can help researchers who are working on the immunomodulatory effects of postbiotics in children.DiscussionIf postbiotics-toothpaste prove to be effective in improving the oral immunity, they can be used to prevent dental caries and other oral diseases. The result of this study can help researchers who are working on the immunomodulatory effects of postbiotics in children.Iranian Registry of Clinical Trials (IRCT), IRCT20191016045128N2. Registered on 7 March 2022.Trial registration numberIranian Registry of Clinical Trials (IRCT), IRCT20191016045128N2. Registered on 7 March 2022. Children in mixed dentition are highly at risk for dental caries, which is a major health issue worldwide. Despite their effect in controlling dental caries, using probiotics can be challenging. Therefore, it has been advised to use their inanimate forms, called postbiotics. We hypothesize that postbiotics can enhance the oral immunity. The aim of this triple-blind, randomized, placebo-controlled trial is to investigate the effect of postbiotic-toothpaste ( ) on salivary levels of Immunoglobulin A (IgA) and pH in children. Using comparing two means formula to calculate the sample size, for this trial 80 healthy 6- to 12-year-old children during mixed dentition with no cavitated dental caries will be selected by convenience sampling method and randomly allocated to two groups, postbiotic-toothpaste or placebo-toothpaste. Saliva samples will be gathered at baseline and four weeks after the intervention. The level of salivary IgA will be determined by ELISA and salivary pH will be measured using a pH meter. Data will be compared within and between groups using independent t-test and paired t-test, in case of normality, with a < 0.05 as statistically significant. If postbiotics-toothpaste prove to be effective in improving the oral immunity, they can be used to prevent dental caries and other oral diseases. The result of this study can help researchers who are working on the immunomodulatory effects of postbiotics in children. Iranian Registry of Clinical Trials (IRCT), IRCT20191016045128N2. Registered on 7 March 2022. BackgroundChildren in mixed dentition are highly at risk for dental caries, which is a major health issue worldwide. Despite their effect in controlling dental caries, using probiotics can be challenging. Therefore, it has been advised to use their inanimate forms, called postbiotics. We hypothesize that postbiotics can enhance the oral immunity.MethodsThe aim of this triple-blind, randomized, placebo-controlled trial is to investigate the effect of postbiotic-toothpaste (Bifidobacterium animalis subsp. animalis) on salivary levels of Immunoglobulin A (IgA) and pH in children. Using comparing two means formula to calculate the sample size, for this trial 80 healthy 6- to 12-year-old children during mixed dentition with no cavitated dental caries will be selected by convenience sampling method and randomly allocated to two groups, postbiotic-toothpaste or placebo-toothpaste. Saliva samples will be gathered at baseline and four weeks after the intervention. The level of salivary IgA will be determined by ELISA and salivary pH will be measured using a pH meter. Data will be compared within and between groups using independent t-test and paired t-test, in case of normality, with a p < 0.05 as statistically significant.DiscussionIf postbiotics-toothpaste prove to be effective in improving the oral immunity, they can be used to prevent dental caries and other oral diseases. The result of this study can help researchers who are working on the immunomodulatory effects of postbiotics in children.Trial registration numberIranian Registry of Clinical Trials (IRCT), IRCT20191016045128N2. Registered on 7 March 2022. |
| Author | Saadatzadeh, Afrooz Basir, Leila Cheraghian, Bahman Khanehmasjedi, Samaneh Moghimipour, Eskandar |
| AuthorAffiliation | 3 Department of Food and Drug Control, Faculty of Pharmacy , Ahvaz Jundishapur University of Medical Sciences , Ahvaz , Iran 1 Department of Pediatric Dentistry, School of Dentistry , Ahvaz Jundishapur University of Medical Sciences , Ahvaz , Iran 5 Infectious and Tropical Diseases Research Center , Health Research Institute, Ahvaz Jundishapur University of Medical Sciences , Ahvaz , Iran 4 Department of Biostatistics and Epidemiology, School of Public Health , Alimentary Tract Research Center, Clinical Sciences Research Institute, Ahvaz Jundishapur University of Medical Sciences , Ahvaz , Iran 2 Department of Pharmaceutics, School of Pharmacy, Nanotechnology Research Center , Ahvaz Jundishapur University of Medical Sciences , Ahvaz , Iran |
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| Keywords | saliva serum globulins proteins oral health hydrogen-Ion concentration immunity probiotics |
| Language | English |
| License | 2022 Basir, Moghimipour, Saadatzadeh, Cheraghian and Khanehmasjedi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Abbreviations IgA, immunoglobulin A; ISAPP, international scientific association of probiotics and prebiotics; TNF-α, tumor necrosis factor. ORCID Leila Basir orcid.org/0000-0002-1684-1774 Eskandar Moghimipour orcid.org/0000-0002-6686-2485 Afrooz Saadatzadeh orcid.org/0000-0002-3275-5374 Bahman Cheraghian orcid.org/0000-0001-5446-6998 Samaneh Khanehmasjedi orcid.org/0000-0001-7736-7773 Reviewed by: Lucianne Cople Maia, Federal University of Rio de Janeiro, Brazil Prathip Phantumvanit, Thammasat University, Thailand Dorota Olczak-Kowalczyk, Medical University of Warsaw, Poland Edited by: Tatiana Fidalgo, Rio de Janeiro State University, Brazil Specialty section: This article was submitted to Pediatric Immunology, a section of the journal Frontiers in Pediatrics |
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| Title | Effect of postbiotic-toothpaste on salivary levels of IgA in 6- to 12-year-old children: Study protocol for a randomized triple-blind placebo-controlled trial |
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