Effect of application time of 38% silver diamine fluoride solution on arresting early childhood caries in preschool children: a randomised double-blinded controlled trial protocol

Iliana Gehui Yan, Faith Miaomiao Zheng, Sherry Shiqian Gao, Duangporn Duangthip, Edward Chin Man Lo, Chun Hung Chu, Iliana Gehui Yan, Faith Miaomiao Zheng, Sherry Shiqian Gao, Duangporn Duangthip, Edward Chin Man Lo, Chun Hung Chu

Abstract

Background: To study the caries lesion activity response to topical 38% silver diamine fluoride (SDF) therapy with increasing treatment application time.

Methods/design: The design is a stratified-randomised, double-blind, active-controlled, parallel-group clinical trial with nine treatment arms. The trial will involve recruiting at least 414 3- to 5-year-old kindergarten children with caries, who will receive approximately 0.004 mL of 38% SDF (the typical amount applied per the manufacturer's instructions) to treat each caries lesion. The children will be stratified by caries status, randomised by blocks, and allocated to nine groups of SDF application times: 3, 5, 10, 15, 30, 45, 60, 120, and 180 s. The outcome measure is caries lesion activity (active/arrest) at the tooth-surface level at 6 months post-initial treatment. A calibrated dentist will conduct the blinded clinical examinations at baseline and at the 6-month follow-up. In addition, the parents will be surveyed to examine the effects of the moderating variables, such as oral hygiene, on caries lesion activity. The hypothesis is that a monotonically increasing trend can be found between the SDF application time and the proportion of caries lesions that are arrested. The Cochran-Armitage test for trends in proportions, corrected for clustering within children, will be used to determine the relationship between the exposure to SDF (the SDF application time) and the response (proportion of lesions arrested) in children, taking into consideration the effect of the moderating variables as well as the nesting of multiple caries lesions within an individual child. An EC 80 analysis (an 80% maximal concentration) will be used to determine the exposure (the SDF application time) for 80% caries lesion arrest. Bootstrap methods will be used for clustered data and will be resampled by clustering to determine the 95% confidence interval.

Discussion: This study will help with determining the optimal application time for SDF treatment. It will provide an evidence-based protocol for the use of SDF to arrest tooth decay in the primary teeth of young children. The results will inform an evidence-based SDF protocol to arrest caries, which affects 573 million children with tooth decay worldwide.

Trial registration: ClinicalTrials.gov NCT04655430 . Registered on 7th December 2020.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Schedule of enrolment, intervention, and assessments of application time of 38% silver diamine fluoride (SDF) solution to arrest early childhood caries in preschool children
Fig. 2
Fig. 2
Flow diagram of the randomised clinical trial of the effects of 38% silver diamine fluoride (SDF) application time on arresting early childhood caries

References

    1. Duangthip D, Fung MHT, Wong MCM, Chu CH, Lo ECM. Adverse effects of silver diamine fluoride treatment among preschool children. J Dent Res. 2018;97:395–401. doi: 10.1177/0022034517746678.
    1. Chu CH. Treatment of early childhood caries: a review and case report. Gen Dent. 2000;48:142–148.
    1. Chu CH, Fung DS, Lo EC. Dental caries status of preschool children in Hong Kong. Br Dent J. 1999;187:616–620. doi: 10.1038/sj.bdj.4800347.
    1. Chu CH, Ho PL, Lo EC. Oral health status and behaviours of preschool children in Hong Kong. BMC Public Health. 2012;12:767. doi: 10.1186/1471-2458-12-767.
    1. Chu CH, Lo EC. Promoting caries arrest in children with silver diamine fluoride: a review. Oral Health Prev Dent. 2008;6:315–321.
    1. Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002;81:767–770. doi: 10.1177/0810767.
    1. Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009;88:116–125. doi: 10.1177/0022034508329406.
    1. Milgrom P, Chi DL. Prevention-centered caries management strategies during critical periods in early childhood. J Calif Dent Assoc. 2011;39:735–741.
    1. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. Jama. 2012;308:2594–2604. doi: 10.1001/jama.2012.87802.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Gao SS, Zheng FM, Chen KJ, Duangthip D, Lo ECM, Chu CH. Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial. Trials. 2021;22:519. doi: 10.1186/s13063-021-05496-y.
    1. Chen KJ, Liu J, Xu B, Li Y, Li Y, Zhang S, et al. Oral health status of 12-year-old children in Lisu minority ethnic group in China: a cross-sectional study. BMC Oral Health. 2021;21:27. doi: 10.1186/s12903-020-01358-2.
    1. Gao SS, Chen KJ, Duangthip D, Wong MCM, Lo ECM, Chu CH. Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial. Trials. 2020;21:140. doi: 10.1186/s13063-020-4088-7.
    1. Fung MHT, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized clinical trial of 12% and 38% silver diamine fluoride treatment. J Dent Res. 2018;97:171–178. doi: 10.1177/0022034517728496.
    1. Li R, Lo EC, Liu BY, Wong MC, Chu CH. Randomized clinical trial on arresting dental root caries through silver diammine fluoride applications in community-dwelling elders. J Dent. 2016;51:15–20. doi: 10.1016/j.jdent.2016.05.005.
    1. Chu CH, Gao SS, Li SK, Wong MC, Lo EC. The effectiveness of the biannual application of silver nitrate solution followed by sodium fluoride varnish in arresting early childhood caries in preschool children: study protocol for a randomised controlled trial. Trials. 2015;16:426. doi: 10.1186/s13063-015-0960-2.
    1. Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. Fluoride delivered via a topical application of 38% SDF and 5% NaF. Int Dent J. 2022. (accepted).
    1. Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. Randomized clinical trial on sodium fluoride with tricalcium phosphate. J Dent Res. 2021; 100: 66-73. https:// 10.1177/0022034520952031.
    1. Gao SS, Zhao IS, Hiraishi N, Duangthip D, Mei ML, Lo ECM, et al. Clinical trials of silver diamine fluoride in arresting caries among children: a systematic review. JDR Clin Trans Res. 2016;1:201–210. doi: 10.1177/2380084416661474.
    1. Nam IW. Case studies of alveoloplasty in patients in need of complete dentures. Taehan Chikkwa Uisa Hyophoe Chi. 1987;25:439–445.
    1. Twisk JWR. Applied multilevel analysis: a practical guide for medical researchers. Cambridge: Cambridge University Press; 2006.
    1. Gao SS, Chen KJ, Duangthip D, Wong MCM, Lo ECM, Chu CH. Arresting early childhood caries using silver and fluoride products - a randomised trial. J Dent. 2020;103:103522. doi: 10.1016/j.jdent.2020.103522.
    1. Seifo N, Robertson M, MacLean J, Blain K, Grosse S, Milne R, et al. The use of silver diamine fluoride (SDF) in dental practice. Br Dent J. 2020;228:75–81. doi: 10.1038/s41415-020-1203-9.
    1. Clemens J, Gold J, Chaffin J. Effect and acceptance of silver diamine fluoride treatment on dental caries in primary teeth. J Public Health Dentist. 2018;78:63–68. doi: 10.1111/jphd.12241.
    1. Crystal YO, Niederman R. Evidence-based dentistry update on silver diamine fluoride. Dent Clin North Am. 2019;63:45–68. doi: 10.1016/j.cden.2018.08.011.
    1. Cibulka MT, Strube MJ. The conundrum of kappa and why some musculoskeletal tests appear unreliable despite high agreement: a comparison of Cohen kappa and Gwet’s AC to assess observer agreement when using nominal and ordinal data. Phys Ther. 2021. 10.1093/ptj/pzab150.
    1. Cochran WG. Some methods for strengthening the common X2 tests. Bioethics. 1954;10:417.
    1. Kreiss J-P, Lahiri SN. 1 - Bootstrap methods for time series. In: Subba Rao T, Subba Rao S, Rao CR, editors. Handbook of Statistics: Elsevier; 2012. p. 3–26. .
    1. McCoy CE. Understanding the intention-to-treat principle in randomized controlled trials. Western J Emerg Med. 2017;18:1075–1078. doi: 10.5811/westjem.2017.8.35985.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner