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.

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.