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Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial

BACKGROUND: Silver diamine fluoride (SDF) and sodium fluoride (NaF) are widely used for caries management. The objectives of this study are (i) to compare the caries-arresting and caries-preventive effects of SDF and NaF in young children, (ii) to determine children’s and parents’ acceptance of thes...

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Autores principales: Gao, Sherry Shiqian, Zheng, Faith Miaomiao, Chen, Kitty Jieyi, Duangthip, Duangporn, Lo, Edward Chin Man, Chu, Chun Hung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8335970/
https://www.ncbi.nlm.nih.gov/pubmed/34348775
http://dx.doi.org/10.1186/s13063-021-05496-y
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author Gao, Sherry Shiqian
Zheng, Faith Miaomiao
Chen, Kitty Jieyi
Duangthip, Duangporn
Lo, Edward Chin Man
Chu, Chun Hung
author_facet Gao, Sherry Shiqian
Zheng, Faith Miaomiao
Chen, Kitty Jieyi
Duangthip, Duangporn
Lo, Edward Chin Man
Chu, Chun Hung
author_sort Gao, Sherry Shiqian
collection PubMed
description BACKGROUND: Silver diamine fluoride (SDF) and sodium fluoride (NaF) are widely used for caries management. The objectives of this study are (i) to compare the caries-arresting and caries-preventive effects of SDF and NaF in young children, (ii) to determine children’s and parents’ acceptance of these fluoride therapies and (iii) to investigate the short-term (1 day) and long-term (1 year) adverse effects of these fluoride therapies. METHODS/DESIGN: This is a randomised, double-blind, active-controlled clinical trial to be conducted in Hong Kong kindergartens. The study has received approval from the local institutional review board. Written consent will be obtained from the parents/guardians before the study. The study will recruit at least 688 healthy 3-year-old children. This sample size is sufficient for an appropriate statistical analysis. Stratified randomisation will be performed for intervention allocation. The two intervention groups are 38% SDF and 5% NaF varnish applied on six primary upper anterior teeth. At baseline, one trained examiner will perform clinical examinations of the children in the kindergartens. The caries experience and oral hygiene status of each child will be recorded using the decayed, missing (due to caries) and filled primary tooth index and visual plaque index, respectively. Then, an independent operator will apply the assigned fluoride after the dental examinations. The examiner, the children and their parents will be blinded to the intervention allocation. In addition, a research assistant will evaluate the child’s acceptance using interval rating scales for children’s uncooperative behaviour. The examiner will then visit the children the next day to study the short-term potential adverse effects of the fluoride therapies. The same examiner will perform a follow-up examination after 1 year to evaluate the children’s caries experiences, their oral hygiene statuses and the adverse effects of the fluoride. Parental questionnaires will be used to assess parental satisfaction and concerns about the fluoride therapies. DISCUSSION: This study provides essential information about using SDF in an outreach kindergarten service for caries management from different aspects, which include the caries-arresting and caries-preventive effects, the adverse effects and children’s and parents’ acceptance. The success of the service can help to increase the adoption of SDF to reduce the global burden of early childhood caries. TRIAL REGISTRATION: ClinicalTrials.gov NCT04399369. Registered on May 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05496-y.
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spelling pubmed-83359702021-08-04 Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial Gao, Sherry Shiqian Zheng, Faith Miaomiao Chen, Kitty Jieyi Duangthip, Duangporn Lo, Edward Chin Man Chu, Chun Hung Trials Study Protocol BACKGROUND: Silver diamine fluoride (SDF) and sodium fluoride (NaF) are widely used for caries management. The objectives of this study are (i) to compare the caries-arresting and caries-preventive effects of SDF and NaF in young children, (ii) to determine children’s and parents’ acceptance of these fluoride therapies and (iii) to investigate the short-term (1 day) and long-term (1 year) adverse effects of these fluoride therapies. METHODS/DESIGN: This is a randomised, double-blind, active-controlled clinical trial to be conducted in Hong Kong kindergartens. The study has received approval from the local institutional review board. Written consent will be obtained from the parents/guardians before the study. The study will recruit at least 688 healthy 3-year-old children. This sample size is sufficient for an appropriate statistical analysis. Stratified randomisation will be performed for intervention allocation. The two intervention groups are 38% SDF and 5% NaF varnish applied on six primary upper anterior teeth. At baseline, one trained examiner will perform clinical examinations of the children in the kindergartens. The caries experience and oral hygiene status of each child will be recorded using the decayed, missing (due to caries) and filled primary tooth index and visual plaque index, respectively. Then, an independent operator will apply the assigned fluoride after the dental examinations. The examiner, the children and their parents will be blinded to the intervention allocation. In addition, a research assistant will evaluate the child’s acceptance using interval rating scales for children’s uncooperative behaviour. The examiner will then visit the children the next day to study the short-term potential adverse effects of the fluoride therapies. The same examiner will perform a follow-up examination after 1 year to evaluate the children’s caries experiences, their oral hygiene statuses and the adverse effects of the fluoride. Parental questionnaires will be used to assess parental satisfaction and concerns about the fluoride therapies. DISCUSSION: This study provides essential information about using SDF in an outreach kindergarten service for caries management from different aspects, which include the caries-arresting and caries-preventive effects, the adverse effects and children’s and parents’ acceptance. The success of the service can help to increase the adoption of SDF to reduce the global burden of early childhood caries. TRIAL REGISTRATION: ClinicalTrials.gov NCT04399369. Registered on May 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05496-y. BioMed Central 2021-08-04 /pmc/articles/PMC8335970/ /pubmed/34348775 http://dx.doi.org/10.1186/s13063-021-05496-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Gao, Sherry Shiqian
Zheng, Faith Miaomiao
Chen, Kitty Jieyi
Duangthip, Duangporn
Lo, Edward Chin Man
Chu, Chun Hung
Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial
title Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial
title_full Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial
title_fullStr Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial
title_full_unstemmed Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial
title_short Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial
title_sort comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8335970/
https://www.ncbi.nlm.nih.gov/pubmed/34348775
http://dx.doi.org/10.1186/s13063-021-05496-y
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