Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial.

INTRODUCTION: Dental caries (tooth decay) is a common disease in which the products of sugar metabolism by certain bacteria that populate the tooth surface induce the development and progression of lesions (cavities). This is a phase II single-centre randomised, double-blind, active-controlled, parallel-group trial to assess the efficacy of a combination povidone iodine and sodium fluoride dental varnish to determine if it is superior to a varnish containing only sodium fluoride in the prevention of new caries lesions. The objective of this report is to describe the rationale and protocol for the trial. METHODS AND ANALYSIS: The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48-84 months old. The primary outcome will be the surface-level primary molar caries increment (d2-3mfs/DMFS) at 2 years post baseline. The incremental dental caries at 1 year will also be compared between the two interventions. The secondary outcome is the Facial Image Scale after the initial treatment and after the fifth treatment at 1 year that gauges the child's response to the treatment. ETHICS AND DISSEMINATION: The Western Institutional Review Board (designated IRB) and the Institutional Review Board of the College of Micronesia-FSM approved all study procedures. The US Food and Drug Administration (FDA) has issued IND 128835 covering this study. The study results will be published and submitted to the FDA in support of a new drug application. TRIALREGISTRATION NUMBER: NCT03082196.

Symptoms with betel nut and betel nut with tobacco among Micronesian youth.

Betel nut has been stated to be addictive, but evidence is lacking. This study describes dependence symptoms among adolescents using betel alone or with tobacco. In the first study, participants were 151 9th graders in Saipan. In the second study, participants were 269 9th graders in Pohnpei and Yap. Participants completed a confidential questionnaire adapted from the U.S. National Survey of Drug Use and Health, which measured dependence symptoms. The 15 items were summed to form a scale, with a range of 0-15, where higher scores indicated greater endorsement of dependence symptoms. In the first study, 39.1% had used betel. More than two-thirds of all users (69.5%) used betel in the previous month: 87.8% also used tobacco with the betel. The mean (SD) dependence symptoms scale score among tobacco users was 8.2±4.0 versus 3.4±2.9 among those who used betel alone [t(7)=3.3, p=0.015]. In the second study, 38% from Pohnpei and 85% from Yap had used betel and most of the current users used it in the previous month (67% from Pohnpei, 91% from Yap). Among those who had used betel in the previous month, 90% from Pohnpei and 64% from Yap were using betel with tobacco. The dependence score was positively associated with frequency of tobacco use (e.g., mean (SD)=11.3 (±2.4) among most frequent users versus a mean (SD)=4.8 (±3.5) among the never users [F(3109)=28.8, p<0.001]). Betel nut users who also use tobacco may benefit from tobacco cessation strategies.

Effectiveness, cost-effectiveness and cost-benefit of a single annual professional intervention for the prevention of childhood dental caries in a remote rural Indigenous community.

BACKGROUND: The aim of the study is to reduce the high prevalence of tooth decay in children in a remote, rural Indigenous community in Australia, by application of a single annual dental preventive intervention. The study seeks to (1) assess the effectiveness of an annual oral health preventive intervention in slowing the incidence of dental caries in children in this community, (2) identify the mediating role of known risk factors for dental caries and (3) assess the cost-effectiveness and cost-benefit of the intervention. METHODS/DESIGN: The intervention is novel in that most dental preventive interventions require regular re-application, which is not possible in resource constrained communities. While tooth decay is preventable, self-care and healthy habits are lacking in these communities, placing more emphasis on health services to deliver an effective dental preventive intervention. Importantly, the study will assess cost-benefit and cost-effectiveness for broader implementation across similar communities in Australia and internationally. DISCUSSION: There is an urgent need to reduce the burden of dental decay in these communities, by implementing effective, cost-effective, feasible and sustainable dental prevention programs. Expected outcomes of this study include improved oral and general health of children within the community; an understanding of the costs associated with the intervention provided, and its comparison with the costs of allowing new lesions to develop, with associated treatment costs. Findings should be generalisable to similar communities around the world. The research is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), registration number ACTRN12615000693527; date of registration: 3rd July 2015.

Cluster-randomized xylitol toothpaste trial for early childhood caries prevention.

PURPOSE: The purpose of this study was to assess the efficacy of supervised tooth-brushing with xylitol toothpaste to prevent early childhood caries (ECC) and reduce mutans streptococci. METHODS: In this cluster-randomized efficacy trial, 196 four- to five-year-old children in four Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400 ppm/31 percent fluoride xylitol or 1,450 ppm fluoride sorbitol toothpaste. We hypothesized that there would be no difference in efficacy between the two types of toothpaste. The primary outcome was the surface-level primary molar caries increment (d(2-3)mfs) after six months. A single examiner was blinded to classroom assignments. Two classrooms were assigned to the fluoride-xylitol group (85 children), and two classrooms were assigned to the fluoride-sorbitol group (83 children). The child-level analyses accounted for clustering. RESULTS: There was no difference between the two groups in baseline or end-of-trial mean d(2-3)mfs. The mean d(2-3)mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group (2.5 and 1.4 d(2-3)mfs, respectively), but the difference was not significant (95% confidence interval: -0.17, 2.37; P=.07). No adverse effects were reported. CONCLUSION: After six months, brushing with a low-strength xylitol/fluoride tooth-paste is no more efficacious in reducing ECC than a fluoride-only toothpaste in a high caries-risk child population.

Areca use among adolescents in Yap and Pohnpei, the Federated States of Micronesia.

OBJECTIVE: Areca (Betel Nut) is the fourth most commonly used psychoactive drug throughout the world and is legal in U.S. It is carcinogenic. Within a health program in the Federated States of Micronesia we surveyed use among adolescents. METHODS: One hundred 7th and 8th graders in Yap and Pohnpei were surveyed and clinical oral examinations conducted. The questionnaire included items on Areca: age first used Areca, whether peers or family members used Areca, frequency of use, whether tobacco was used, and source of Areca. Questions also assessed anxiety and depression. Two scales assessed getting along with other kids and adaptation to school. RESULTS: 61.5-71.4% of adolescents had ever used Areca and 54.7-68.6% used it at least once in the last month. CONCLUSION: Most adolescents surveyed in Yap and Pohnpei used Areca, which may place these youth at increased risk for cancer and health disparities.

Topical iodine and fluoride varnish effectiveness in the primary dentition: a quasi-experimental study.

PURPOSE: Combining fluorides with antimicrobials may be of value because fluorides alone do not provide complete protection. The purpose of this quasi-experimental study was to compare the effectiveness of combined topical treatment with 10% polyvinyl-pyrollidone iodine (PVP-I) and 5% sodium fluoride varnish (FV) with FV alone. METHODS: One hundred seventy-two 12- to 30-month-old children received either combined or single therapy in Majuro, Republic of the Marshall Islands, between June 2008 and March 2009. The children received a mean of 2.5 treatments in the PVP-I combined group (range=2-3) and 2.8 treatments in the FV group (range=2-4) and were then examined. RESULTS: The percentage of children with any new decayed primary teeth was 41% (n=81) in the PVP-I combined group and 54% (n=90) in the FV group. Multivariate log-binomial regression was used to compare the rate of any new decay between groups, controlling for the number of teeth at baseline and the number of treatment visits. The risk ratio for treatment is 0.69 (95% confidence interval [CI]=0.51-0.94). No adverse effects were observed. CONCLUSION: Combined treatment with 10% polyvinylpyrollidone iodine and 5% sodium fluoride varnish reduced the rate of new tooth decay by 31% over fluoride varnish alone.

Empowering Head Start to improve access to good oral health for children from low income families.

Surveys over 20 years have documented worsening in the dental health of preschoolers. Healthy People 2010 Midcourse Review reports the country moving away from oral health goals for young children; the slip is 57%. Exacerbating this is the inability of Medicaid to provide for those in need. Most children receive examinations only: few receive comprehensive care. We urge Head Start grantees to adopt a new approach to oral health goals and in this paper offer: (1) a review of the problem and premises preventing a solution; (2) a proposal that Head Start adopt a public health perspective; and (3) specific roles staff and dental personnel can take to mount aggressive strategies to arrest tooth decay at the grantee site.

Topical iodine and fluoride varnish combined is more effective than fluoride varnish alone for protecting erupting first permanent molars: a retrospective cohort study.

OBJECTIVE: This communication examines the combined effect of topical polyvinylpyrollidone (PVP)-iodine plus fluoride varnish in the prevention of tooth decay in erupting first permanent molars in an ongoing public health program. METHODS: The evaluation employed a retrospective cohort design with two groups of children 60-83 months. Cohort 1 (2004-05) received three times per school year topical fluoride varnish, and Cohort 2 (2008-09) received topical application of 10 percent PVP-iodine followed at each visit with topical fluoride varnish. The children were examined clinically at the beginning and end of the school year. RESULTS: The proportion of children with caries-free first permanent molars in Cohort 2 (PVP-iodine plus fluoride varnish) was 0.883 and was greater than that in Cohort 1 (varnish), which was 0.785 (Chi-square = 1.000E1, df 1, P < 0.002). CONCLUSIONS: This evaluation of an ongoing dental public health program adds evidence that topical antiseptics applied at the same time as fluoride varnish are more effective than varnish alone. Randomized trials are needed.

Xylitol pediatric topical oral syrup to prevent dental caries: a double-blind randomized clinical trial of efficacy.

OBJECTIVES: To evaluate the effectiveness of a xylitol pediatric topical oral syrup to reduce the incidence of dental caries among very young children and to evaluate the effect of xylitol in reducing acute otitis media in a subsequent study. DESIGN: Double-blind randomized controlled trial. SETTING: Communities in the Republic of the Marshall Islands. PARTICIPANTS: One hundred eight children aged 9 to 15 months were screened, and 100 were enrolled. Intervention Children were randomized to receive xylitol topical oral syrup (administered by their parents) twice a day (2 xylitol [4.00-g] doses and 1 sorbitol dose) (Xyl-2 x group) or thrice per day (3 xylitol [2.67-g] doses) (Xyl-3x group) vs a control syrup (1 xylitol [2.67-g] dose and 2 sorbitol doses) (control group). MAIN OUTCOME MEASURES: The primary outcome end point of the study was the number of decayed primary teeth. A secondary outcome end point was the incidence of acute otitis media for reporting in a subsequent report. RESULTS: Ninety-four children (mean [SD] age, 15.0 [2.7] months at randomization) with at least 1 follow-up examination were included in the intent-to-treat analysis. The mean (SD) follow-up period was 10.5 (2.2) months. Fifteen of 29 of the children in the control group (51.7%) had tooth decay compared with 13 of 32 children in the Xyl-3x group (40.6%) and eight of 33 children in the Xyl-2x group (24.2%). The mean (SD) numbers of decayed teeth were 1.9 (2.4) in the control group, 1.0 (1.4) in the Xyl-3x group, and 0.6 (1.1) in the Xyl-2x group. Compared with the control group, there were significantly fewer decayed teeth in the Xyl-2x group (relative risk, 0.30; 95% confidence interval, 0.13-0.66; P = .003) and in the Xyl-3x group (0.50; 0.26-0.96; P = .04). No statistical difference was noted between the 2 xylitol treatment groups (P = .22). CONCLUSION: Xylitol oral syrup administered topically 2 or 3 times daily at a total daily dose of 8 g was effective in preventing early childhood caries.

Evaluation of Pacific Islands Early Childhood Caries Prevention Project: Republic of the Marshall Islands.

OBJECTIVES: This communication reports an outcomes evaluation of the Pacific Islands Early Childhood Caries Prevention Project. METHODS: The evaluation includes children in three conditions: a) topical fluoride varnish three times per school year; b) varnish plus twice-per-day toothbrushing; and c) intervention 2 plus three-times-per-day xylitol containing gummy bear snacks at school and home visits to encourage parental involvement. For this evaluation, groups 2 and 3 have been combined. RESULTS: One year after project implementation, mean decayed, extracted, or filled primary teeth was 10.3 [standard deviation (SD)= 4.3] teeth for group 1, and 8.2 (SD = 4.0) teeth for the combination of groups 2 and 3 (P < 0.05). Twenty-four percent of group 1 had cavitated lesions in any permanent molar versus 12.8 percent in groups 2 and 3 combined (P > 0.05). CONCLUSION: Evaluation confirms the outcome of a program including both in-school twice-daily toothbrushing with fluoridated toothpaste and frequent applications of fluoride varnish.

Dental manpower development in the Pacific: case study in the Republic of the Marshall Islands.

This case study reports the ongoing progress and results of a manpower development program to expand indigenous dental personnel at four levels in the Republic of the Marshall Islands. The program was designed to: 1) increase the number of Marshallese students who successfully complete dentistry training; 2) recruit and train a group of Marshallese high school graduates in dental assisting for service in new preventive outreach programs within the community; 3) enhance the dental training of health assistants providing primary medical care to outer islands away from the main population centers of Majuro and Ebeye; and 4) provide in-service training on tooth decay prevention for Head Start teachers. The program resulted in the training of one Marshallese dentist and two Marshallese dental therapist, 16 primary care health aides who received oral health training for work in the outer island dispensaries, and 200 Head Start and kindergarten teachers who completed in-service training in oral health. Additional expertise was shared with other United States Affiliated Pacific Islands (USAPI) to enhance the dental workforce throughout the Pacific.

Republic of the Marshall Islands: planning and implementation of a dental caries prevention program for an island nation.

The Republic of Marshall Islands (R.M.I.) is an island state in eastern Micronesia with a landmass of 70 square miles scattered across 750,000 square miles of the western Pacific Ocean with a national population of approximately 51,000. In a 2002 children's oral health survey, 85 percent of six year old children in the R.M.I. capital of Majuro were found to have had at least one carious tooth and 65 percent had 5 or more affected teeth. The mean caries prevalence among primary (or baby) teeth was 5.79 decayed or filled teeth (dft), a caries prevalence rate close to three times the U.S. national mean. While 12.3 percent were caries-free, 65.0 percent had experienced 5 or more affected teeth (rampant caries). Of these, less than 1 percent had received any form of dental treatment. Comparably remarkable early childhood dental disease rates were also observed on other populated islands and atolls. In response to the rampant dental disease shown to be affecting young children, the R.M.I. Ministry of Health has proposed the implementation of a strategy targeting the pre-natal / pen-natal environment, young parents, pre-school and elementary school children.