Calibration of dentists for Caries Management by Risk Assessment Research in a Practice Based Research Network - CAMBRA PBRN.

BACKGROUND: To prove that Caries Management by Risk Assessment (CAMBRA) can be successfully implemented in dental practices outside of the university setting, dentists in the San Francisco Bay Area (CA) were approached to participate in a Practice Based Research Network (PBRN) study. The overall goal of the CAMBRA-PBRN study was to recruit 30 dentists to perform a two-year study involving approximately 900 patients. Goal of the calibration study was to standardize and calibrate dentists potentially participating in the CAMBRA-PBRN study. METHODS: To minimize inter-examiner variability in data collection, including classification of carious lesions and recording of existing restorations, participating dentists were trained and calibrated in accurate DMFS (decayed, missing, filled surfaces) charting. Dentists were also trained and calibrated to diagnose and differentiate between sound surfaces and non-cavitated caries lesions (International Caries Detection and Assessment - ICDAS scores 1 and 2) for posterior occlusal surfaces. Thirty dentists were calibrated to a single gold standard examiner (BJ) during 6 calibration sessions, between 2011 and 2014. Kappa statistics were used to determine inter-examiner reliability on 13 or more patients, aged 12-63 (average age 38 ± 15 years), per examiner during each session, resulting in 94 patient encounters over the course of all 6 sessions. To participate in the main study, examiners needed to achieve a minimum required kappa of 0.75. During the calibration process, examiners scored between 1036 and 2220 tooth surfaces. RESULTS: The kappa values (unweighted kappa) of the participating dentists compared to the gold standard examiner ranged from 0.75 to 0.90, with an average kappa of 0.84 ± 0.03. 90% of the examiners achieved overall kappa values above 0.8. However, separate reliability for assessment of non-cavitated lesions, as in other studies, was lower (0.55 ± 0.15). Multiple subcategories were evaluated. All dentists reached sufficient reliability values to proceed into the study; nevertheless, one dentist discontinued with the study due to scheduling conflicts. CONCLUSIONS: The high inter-examiner reliability results have shown that dentists who work in primarily non-research based practices can be effectively standardized and calibrated in data collection, based on specific guidelines created to anticipate potential research study scenarios.

Mother and youth access (MAYA) maternal chlorhexidine, counselling and paediatric fluoride varnish randomized clinical trial to prevent early childhood caries.

BACKGROUND: Mexican-American children have a higher caries prevalence than the U.S. 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 counselling. 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 [(d(2+) 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 counselling and preventive child FV applications were not more efficacious than maternal counselling with child therapeutic FV for precavitated lesions for ECC prevention. FV for young children with brief maternal CHX use and oral health counselling may need to be combined with additional or longer-term therapies to significantly reduce ECC in high-risk populations.

Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial.

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.

Monetary incentives for improving smartphone-measured oral hygiene behaviors in young children: A randomized pilot trial.

AIMS: To assess feasibility, acceptability, and early efficacy of monetary incentive-based interventions on fostering oral hygiene in young children measured with a Bluetooth-enabled toothbrush and smartphone application. DESIGN: A stratified, parallel-group, three-arm individually randomized controlled pilot trial. SETTING: Two Los Angeles area Early Head Start (EHS) sites. PARTICIPANTS: 36 parent-child dyads enrolled in an EHS home visit program for 0-3 year olds. INTERVENTIONS: Eligible dyads, within strata and permuted blocks, were randomized in equal allocation to one of three groups: waitlist (delayed monetary incentive) control group, fixed monetary incentive package, or lottery monetary incentive package. The intervention lasted 8 weeks. OUTCOMES: Primary outcomes were a) toothbrushing performance: mean number of Bluetooth-recorded half-day episodes per week when the child's teeth were brushed, and b) dental visit by the 2-month follow-up among children with no prior dental visit. The a priori milestone of 20% more frequent toothbrushing identified the intervention for a subsequent trial. Feasibility and acceptability measures were also assessed, including frequency of parents syncing the Bluetooth-enabled toothbrush to the smartphone application and plaque measurement from digital photographs. FINDINGS: Digital monitoring of toothbrushing was feasible. Mean number of weekly toothbrushing episodes over 8 weeks was 3.9 in the control group, 4.1 in the fixed incentive group, and 6.0 in the lottery incentive group. The lottery group had 53% more frequent toothbrushing than the control group and 47% more frequent toothbrushing than the fixed group. Exploratory analyses showed effects concentrated among children ≤24 months. Follow-up dental visit attendance was similar across groups. iPhone 7 more reliably captured evaluable images than Photomed Cannon G16. CONCLUSIONS: Trial protocol and outcome measures were deemed feasible and acceptable. Results informed the study protocol for a fully powered trial of lottery incentives versus a delayed control using the smart toothbrush and remote digital incentive program administration. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03862443.

The Kidney and Periodontal Disease (KAPD) study: A pilot randomized controlled trial testing the effect of non-surgical periodontal therapy on chronic kidney disease.

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 un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical 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 59.2years (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 non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials.

Examination criteria and calibration procedures for prevention trials of the Early Childhood Caries Collaborating Centers.

OBJECTIVES: To summarize diagnostic criteria and examiner training and calibration of the National Institute of Dental and Craniofacial Research-funded Early Childhood Caries Collaborating Centers (EC4) and report examiner calibration results from 2010 to 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- to 5-year-old children in the San Francisco Mission District in which assessments from each examiner to be calibrated were compared with those from a single gold standard examiner from 2010 to 2014. Cohen's kappa statistic was used to determine inter-examiner agreement. RESULTS: A total of seven 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 noncavitated lesions, as in other studies, was lower. CONCLUSIONS: An experienced multidisciplinary 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.

Implementing an infant oral care program.

The American Academy of Pediatric Dentistry, American Dental Association, American Public Health Association, Association of State and Territorial Dental Directors, California Dental Association, and California Society of Pediatric Dentists currently recommend that children receive their first dental evaluation within the first year of life. Providing early care to children from ages 6 months to 5 years offers an opportunity to educate and inform parents about their children's oral health. Anticipatory guidance - counseling of parents by health providers about developmental changes that will occur in their children between health visits - for children's dental health is an important part of preventive care. It may be the most effective way to prevent problems that traditional infectious disease models have failed to address, such as early childhood caries. The model of anticipatory guidance is valuable for dental professionals because it emphasizes prevention of dental problems rather than restorative care. A comprehensive infant oral care program utilizes (1) oral health assessment at regularly scheduled dental visits, (2) risk assessments, (3) counseling sessions with parents during either regular dental visits or additional visits scheduled if a child is deemed at risk, (4) preventive treatment such as the application of fluoride varnish or sealants, and (5) outreach and incentives to reinforce attendance. Facilitating access to early and regular dental care is a crucial part of any effective intervention strategy, and intervention techniques should be tailored to the community being served.

Recruiting and retaining pregnant women from a community health center at the US-Mexico border for the Mothers and Youth Access clinical trial.

BACKGROUND: Recruitment and retention in clinical trials of minorities is low, particularly in rural underserved populations. This has slowed progress in addressing racial/ethnic disparities in oral health. PURPOSE: To describe factors associated with successful recruitment, and identify predictors of continued retention of pregnant women attending a community health center into a randomized controlled clinical trial to prevent early childhood caries. METHODS: The Mothers and Youth Access (MAYA) Trial recruited women in the second trimester of pregnancy. At baseline, consenting women completed an oral health questionnaire and received a dental exam and oral health counseling. Four months postpartum, women returned with their babies for randomization with follow up at 9-, 12-, 18-, 24-, 30-, and 36-month postpartum visits. To assess predictors of retention, data about respondents' demographics, and oral health-related knowledge, attitudes, and behaviors were obtained by questionnaire and analyzed by logistic and discrete time-to-event regression analyses. RESULTS: Of 556 predominantly Mexican-American women recruited at baseline, 195 (35%) were excluded after baseline for not meeting inclusion criteria; 361 (65%) continued to randomization. Factors such as race/ethnicity, annual household income, household composition, oral health-related knowledge and behaviors significantly related to retention until randomization. In multivariable models, women reporting a higher annual household income were less likely to be lost to attrition before randomization (odds ratio = 0.73, 95% confidence interval (CI) 0.60-0.89); while Mexican/Mexican-American women were less likely to be lost beyond randomization (hazard ratio = 0.53, 95% CI 0.26-1.08). LIMITATIONS: Factors not measured at baseline may have been important in predicting attrition. The MAYA Trial is expected to finish by November 2008; therefore, complete results for total retention may differ from those reported here. CONCLUSIONS: Recruitment and retention efforts for pregnant Hispanic women should place heavy emphasis on culture as ethnicity remained the only borderline significant predictor in postrandomization retention.