Background School-based caries prevention can increase access to critical dental services and reduce oral health inequities. However, little is known regarding the incidence of dental caries in children participating in school caries prevention, and caries diagnosis is often interval censored.
Methods In this paper, we used data from a longitudinal, school-based, randomized clinical trial of minimally invasive treatments for dental caries to estimate the per-visit incidence rate and compare the hazard of dental caries in children receiving either silver diamine fluoride or glass ionomer dental sealants. To account for interval censoring, we used semiparametric transformation models for univariate failure time data and imputed the caries incidence using G-imputation.
Results There were 3040 children that met inclusion criteria for analysis, 1516 (49.9%) of which were randomly assigned to receive silver diamine fluoride and 1524 (50.1%) assigned to receive glass ionomer dental sealants. There were no differences in the hazard of caries between treatments (HR = 0.98, 95% CI = 0.73, 1.24), while children with caries at baseline had a significant increase in the hazard of new caries (HR = 2.54, 95% CI = 2.26, 2.83) compared to those that were caries-free. The per-visit caries incidence ranged from 4.8 to 11.1 per 1000 person-years and increased with each successive study observation.
Conclusions School-based caries prevention can positively affect caries incidence, and results can be used to inform future program design and implementation.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT03442309
Funding StatementThis study was funded by the Patient-Centered Outcomes Research Institute (#PCS160936724)
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The study received ethical approval from the New York University School of Medicine Institutional Review Board.
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Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors after an approved proposal and data use agreemtent, following the schedule of data availability previously published for this trial.
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