Non-inferiority of essential medicines for caries arrest and prevention in a school-based program: Results from the CariedAway pragmatic clinical trial

Abstract

Background: Dental caries is the most common global childhood disease. To control caries, the Centers for Disease Control and Prevention recommends school-based caries prevention, and the World Health Organization lists glass ionomer cement and silver diamine fluoride as essential dental medicines. The CariedAway trial tested the comparative effectiveness of these essential medicines when used in a school-based dental care program. Methods: This cluster-randomized non-inferiority pragmatic trial was conducted in children from 2018 to 2022. Subjects were randomized at the school level to receive either silver diamine fluoride ("simple care") or an active comparator of glass ionomer sealants and atraumatic restorations ("complex care"). All subjects received tooth brushes, fluoride toothpaste, and fluoride varnish. We assessed caries arrest and incidence at two years using mixed-effects multilevel models and two-sample proportion tests with clustering adjustment. Results: 1398 subjects received treatment and completed follow-up observations after two years. The proportion of subjects with arrested caries in simple and complex groups was 0.56 and 0.46, respectively (difference = -0.11, 95% CI = -0.22, 0.01). Prevention rates for no new caries were 0.81 and 0.82 (difference = 0.01, 95% CI = -0.04, 0.06). Conclusions: Over a two-year, non-intervention period, simple care was non-inferior to complex care for both caries arrest and prevention. Results support the utilization of silver diamine fluoride as an arresting and preventive agent in school-based oral health programs and questions the periodicity of current caries prevention recommendations.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT03442309

Funding Statement

Research reported in this publication was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1609-36824). The content is solely the responsibility of the authors and does not necessarily reflect the official views of the funding organization, New York University, or the NYU College of Dentistry.

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This study received ethical approval from the New York University School of Medicine Institutional Review Board (i17-00578). The study is registered at www.clinicaltrials.gov (#NCT03442309).

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Data Availability

The datasets generated and/or analysed during the current study are not publicly available due to the active nature of the trial but are available from the corresponding author on reasonable request.

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