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 inFrontiers in pediatrics Vol. 10; p. 1042973
Main Authors Basir, Leila, Moghimipour, Eskandar, Saadatzadeh, Afrooz, Cheraghian, Bahman, Khanehmasjedi, Samaneh
Format Journal Article
LanguageEnglish
Published Switzerland Frontiers Media S.A 12.12.2022
Subjects
hydrogen-Ion concentration
immunity
oral health
Pediatrics
probiotics
proteins
serum globulins
saliva
serum globulins
proteins
oral health
hydrogen-Ion concentration
immunity
probiotics
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Summary: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.
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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
ISSN:2296-2360
2296-2360
DOI:10.3389/fped.2022.1042973