To determine the efficacy of fluoride varnish (5% NaF, Duraphat ® , Colgate) added to caregiver counseling to prevent early childhood caries, we conducted a two-year randomized, dental-examinermasked clinical trial. Initially, 376 caries-free children, from low-income Chinese or Hispanic San Francisco families, were enrolled (mean age ± standard deviation, 1.8 ± 0.6 yrs). All families received counseling, and children were randomized to the following groups: no fluoride varnish, fluoride varnish once/year, or fluoride varnish twice/year. An unexpected protocol deviation resulted in some children receiving less active fluoride varnish than assigned. Intent-to-treat analyses showed a fluoride varnish protective effect in caries incidence, p < 0.01. Analyzing the number of actual, active fluoride varnish applications received resulted in a dose-response effect, p < 0.01. Caries incidence was higher for 'counseling only' vs. 'counseling + fluoride varnish assigned once/year' (OR = 2.20, 95% CI 1.19-4.08) and 'twice/year' (OR = 3.77, 95% CI 1.88-7.58). No related adverse events were reported. Fluoride varnish added to caregiver counseling is efficacious in reducing early childhood caries incidence.

Objectives To summarize diagnostic criteria and examiner training and calibration of the NIDCR-funded Early Childhood Caries Collaborating Centers (EC4) and report examiner calibration results from 2010–2014. The EC4 at Boston University, University of Colorado, and University of California San Francisco are performing randomized controlled early childhood caries (ECC) prevention trials with caries as the main outcome measure. Methods The EC4 with University of Iowa consultants developed standardized tooth and tooth surface status examination criteria for use in field conditions, examiner training materials, and examiner calibration and re-calibration methodologies. Calibration and re-calibration were performed with 1–5 year old children in the San Francisco Mission District in which assessments from each examiner to be calibrated were compared to those from a single gold standard examiner from 2010–2014. Cohen’s kappa statistic was used to determine inter-examiner agreement. Results A total of 7 examiners were successfully (re)calibrated during that period, examining a total of 231 children. Overall unweighted Cohen’s kappas for 10 surface conditions exceeded the criterion of 0.70. However, separate agreement for assessment of non-cavitated lesions, as in other studies, was lower. Conclusions An experienced multi-disciplinary and multi-institutional team was able to develop criteria and training materials to anticipate situations and field conditions the main trials would encounter. Examiners were successfully trained and (re)calibrated.

Background Mexican-American children have a higher caries prevalence than the US average. The Mothers and Youth Access (MAYA) study was a randomized clinical trial initiated to address this problem. Aim Comparison of the efficacy of two prevention interventions in reducing early childhood caries (ECC). Design All 361 randomized mother-child dyads received oral health counseling. Beginning at 4 months postpartum, intervention mothers received chlorhexidine (CHX) mouthrinse for 3 months beginning 4 months postpartum and children received fluoride varnish (FV) every 6 months from age 12–36 months. Control group children received FV if precavitated lesions developed. Salivary mutans streptococci (MS) and lactobacilli were assessed. Results No significant difference in children’s 36-month caries incidence between groups; 34% in each group developed caries ((d2+fs) > 0). About half of control group developed precavitated lesions and received therapeutic FV. Maternal MS levels declined during CHX use, but increased when discontinued. Conclusions Maternal postpartum CHX regimen, oral health counseling, and preventive child FV applications were not more efficacious than maternal counseling with child therapeutic FV for precavitated lesions for ECC prevention. FV for young children with brief maternal CHX use and oral health counseling may need to be combined with additional or longer-term therapies to significantly reduce ECC in high-risk populations.

Rationale & Objective Observational studies have suggested that periodontal disease may be a modifiable risk factor for chronic kidney disease (CKD). The Kidney and Periodontal Disease (KAPD) Study was designed to determine the feasibility of conducting a periodontal disease treatment trial among a high-risk (mostly poor and racial/ethnic minority) population and estimate the magnitude and variability of kidney and inflammatory biomarker levels in response to intensive periodontal treatment. Study Design Single-center, unmasked, intention-to-treat, randomized, controlled, pilot trial with 2:1 allocation to the treatment and comparison groups. Setting & Participants English- and Spanish-speaking individuals aged 20 to 75 years receiving primary care within the San Francisco Community Health Network with evidence of both moderate to severe periodontal disease and CKD. Intervention Immediate intensive nonsurgical periodontal treatment versus rescue treatment for progressive disease at baseline and 4, 8, and 12 months. Outcomes Feasibility and process outcomes. Levels of biomarkers of kidney function, kidney injury, and systemic inflammation obtained at baseline and 4 and 12 months. Results KAPD randomly assigned 51 participants to the immediate (34 participants) or rescue (17 participants) groups. 14% dropped out of the study (4 immediate, 3 rescue) and 80% completed all 4 visits of the 12-month protocol (28 immediate, 13 rescue). Fewer than half the teeth recommended for extraction were extracted and 40% of immediate group visits were outside the protocol window. Bleeding on probing and probing depth improved more in the immediate group than in the rescue group; there was no significant separation in periodontal status. Levels of markers of vascular endothelial and systemic injury declined in both groups. Limitations No true control group. Conclusions This 12-month, pilot, randomized, controlled trial successfully recruited and retained a high-risk population but was less successful observing treatment adherence, treatment effect, and variability of biomarker levels. Although KAPD did not meet all of its goals, important lessons learned can be applied to future studies. Funding National Institute of Diabetes and Digestive and Kidney Disease (Bethesda, MD; grant number 1K23DK093710-01A1) and Harold Amos Medical Faculty Development Program of the Robert Wood Johnson Foundation, Princeton, NJ. Funders had no role in study design; collection, analysis, or interpretation of data; writing the report; or the decision to submit the report for publication. Trial Registration NCT01802216 .

Introduction: Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. Methods/design: We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month unblinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive nonsurgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. Results: To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2 years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. Discussion: Results from the KAPD study will provide needed preliminary evidence of the effectiveness of nonsurgical periodontal treatment to slow CKD progression and inform the design future clinical research trials.