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
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...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-12-01
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| Series: | Frontiers in Pediatrics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2022.1042973/full |
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| author | Leila Basir Eskandar Moghimipour Afrooz Saadatzadeh Bahman Cheraghian Samaneh Khanehmasjedi |
| author_facet | Leila Basir Eskandar Moghimipour Afrooz Saadatzadeh Bahman Cheraghian Samaneh Khanehmasjedi |
| author_sort | Leila Basir |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T06:27:23Z |
| format | Article |
| id | doaj.art-55f96991ee7d4c31a5ca1136f8d0323f |
| institution | Directory Open Access Journal |
| issn | 2296-2360 |
| language | English |
| last_indexed | 2024-04-13T06:27:23Z |
| publishDate | 2022-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pediatrics |
| spelling | doaj.art-55f96991ee7d4c31a5ca1136f8d0323f2022-12-22T02:58:21ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602022-12-011010.3389/fped.2022.10429731042973Effect of postbiotic-toothpaste on salivary levels of IgA in 6- to 12-year-old children: Study protocol for a randomized triple-blind placebo-controlled trialLeila Basir0Eskandar Moghimipour1Afrooz Saadatzadeh2Bahman Cheraghian3Samaneh Khanehmasjedi4Department of Pediatric Dentistry, School of Dentistry, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, IranDepartment of Pharmaceutics, School of Pharmacy, Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, IranDepartment of Food and Drug Control, Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, IranDepartment of Biostatistics and Epidemiology, School of Public Health, Alimentary Tract Research Center, Clinical Sciences Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, IranInfectious and Tropical Diseases Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, IranBackgroundChildren 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.https://www.frontiersin.org/articles/10.3389/fped.2022.1042973/fullprobioticsoral healthimmunityproteinsserum globulinshydrogen-Ion concentration |
| spellingShingle | Leila Basir Eskandar Moghimipour Afrooz Saadatzadeh Bahman Cheraghian Samaneh Khanehmasjedi 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 Frontiers in Pediatrics probiotics oral health immunity proteins serum globulins hydrogen-Ion concentration |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | probiotics oral health immunity proteins serum globulins hydrogen-Ion concentration |
| url | https://www.frontiersin.org/articles/10.3389/fped.2022.1042973/full |
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