Diagnostic Testing Accuracy of Sucrose-stimulated Salivary pH for Screening Early Childhood Caries Diagnosis and Severity: An Observational Study

Purpose The purpose of this study was to determine the diagnostic testing accuracy of child and maternal sucrose-stimulated salivary pH as screening tools for early childhood caries diagnosis and severity.

From a sample population of 642 mother-child dyads, with child-subjects under age six years old, child and maternal sucrose-stimulated saliva specimens were collected to measure salivary pH thirty minutes after consumption of sucrose by mouth. Immediately after the pH measurement and oral clinical examination, the pediatric dentist provider determined for child-subjects their diagnoses for early childhood caries and severity, respectively guided by the gold-standard classifications promulgated by the American Academy of Pediatric Dentistry and International Caries Detection and Assessment System. Salivary pH of 6.0 was statistically calculated as the screening cut-off point. Statistical analyses calculated values for true positive, false positive, true negative, false negative, and the diagnostic testing accuracy metrics for prevalence, specificity, sensitivity, diagnostic odds ratio, positive and negative predictive values, positive and negative likelihood ratios, and Youden’s Index. Regression models were utilized to determine the respective odds ratio associations between child and maternal sucrose-stimulated salivary pH versus the diagnosis and severity of early childhood caries.

For early childhood caries diagnosis, child sucrose-stimulated salivary pH yielded diagnostic test accuracy metrics of 47.7 percent prevalence, 72.42 percent specificity, 59.47 percent sensitivity, 66.30 percent positive predictive value, and 66.20 percent negative predictive value, and diagnostic odds ratio 3.85. The results for maternal sucrose-stimulated salivary pH for caries severity were similar in value. Maternal sucrose-stimulated salivary pH displayed lower overall DTA metrics compared to child sucrose-stimulated salivary pH, but both child and maternal sucrose-stimulated salivary pH had higher specificity than sensitivity and displayed moderate levels of positive and negative predictive values. Child sucrose-stimulated salivary pH less than 6.0 had 3.89 times higher odds for ECC diagnosis and 3.56 times higher odds of moderate-extensive caries severity than child sucrose-stimulated salivary pH greater than 6.0. Maternal sucrose-stimulated salivary pH less than 6.0 had 1.60 times higher odds of moderate-extensive caries severity than maternal sucrose-stimulated salivary pH greater than 6.0.

Child and maternal sucrose-stimulated salivary pH screening tests are useful as a screening tool to identify children at high-risk for early childhood caries. Competing Interest Statement The authors have declared no competing interest. Funding Statement This study was funded by the Hansjorg Wyss Department of Plastic Surgery, NYU Langone Hospitals, New York, NY. Author Declarations I 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: IRB of the NYU Grossman School of Medicine gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. 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). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data produced in the present study are available upon reasonable request to the authors.