Abstract
BackgroundDental caries in primary teeth is prevalent, affecting millions of children around the world. Functionalized tricalcium phosphate (fTCP) has been incorporated into sodium fluoride (NaF) varnish to enhance the remineralization process. NaF varnish with the adjunctive application of silver nitrate (AgNO3) solution is effective in arresting dentine caries. So far, there is no published randomized clinical trial investigating the effectiveness of the adoption of AgNO3 solution and NaF varnish containing fTCP in arresting dentine caries in preschool children. The objective of this study is to compare the effectiveness of a 25% AgNO3 solution plus a 5% NaF varnish containing fTCP and a 25% AgNO3 solution plus a 5% NaF varnish in arresting coronal dentine caries among preschool children when applied semi-annually over a 30-month period.Methods/designThis is a randomized, double-blind controlled trial. The null hypothesis tested is that no difference exists between the effectiveness of a 25% AgNO3 solution plus a 5% NaF varnish with fTCP and a 25% AgNO3 solution plus a 5% NaF varnish in arresting dentine caries in preschool children when applied semi-annually. According to the sample size calculation, approximately 2000 3- to 4-year-old kindergarten children will be screened, and at least 408 children with coronal dentine caries will be recruited. The children will be randomly allocated to two treatment groups via stratified randomization: group A – biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and group B – biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish with fTCP. Clinical examinations will be conducted every 6 months to assess whether the carious lesions have become arrested (primary outcome). Confounding factors, such as demographic background and oral hygiene behaviors, will be collected through a parental questionnaire.DiscussionThe effectiveness of the topical application of a 25% AgNO3 solution followed by a 5% NaF varnish with fTCP in arresting coronal dentine caries among preschool children remains unknown. Because the proposed caries-arresting methods are simple, noninvasive and low cost, these can be widely recommended for caries control in young children.Trial registrationClinicalTrials.gov (U.S.): NCT03423797 on 6 February 2018.
Highlights
Dental caries in primary teeth is prevalent, affecting millions of children around the world
The effectiveness of the topical application of a 25% Silver nitrate (AgNO3) solution followed by a 5% NaF varnish with Functionalized tricalcium phosphate (fTCP) in arresting coronal dentine caries among preschool children remains unknown
Because the proposed caries-arresting methods are simple, noninvasive and low cost, these can be widely recommended for caries control in young children
Summary
This is a randomized, double-blind clinical trial aiming to investigate the caries-arresting effectiveness of the semi-annual application of a 25% AgNO3 solution followed by a 5% NaF varnish with/without fTCP among preschool children. The results of the present study will be novel and will provide information regarding the preventive and arresting effect of the application of NaF varnish with/without fTCP following the application of a 25% AgNO3 solution in preschool children. The results of this study will be beneficial for clinicians and dental health policy-makers when adopting noninvasive approaches to tackle the burden of early childhood caries Trial status This randomized clinical trial has been registered in ClinicalTrials.gov (U.S.) with the registration number NCT03423797 (Additional file 3). Abbreviations HKU/HAHKWIRB: Institutional Review Board of The University of Hong Kong/ Hospital Authority Hong Kong West Cluster; AgNO3: Silver nitrate; dmfs: Decayed, missing and filled tooth surfaces; ECOHIS: Early Childhood Oral Health Impact Scale; fTCP: Functionalized tricalcium phosphate; IRB: Institutional Review Board; NaF: Sodium fluoride; SDF: Silver diamine fluoride; SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials; VPI: Visible Plaque Index. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations
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