Combination therapy PVP-iodine and fluoride varnish to reduce early childhood caries in high risk children
Grantee: University of Washington
Principal Investigator: Kiet A. Ly
Project Number: R40MC17163
Project Date: 2/1/2010
Final Report
Age group(s)
- Perinatal/Infancy (0-12 months)
- Toddlerhood (13-35 months)
Targeted/Underserved Population
- Native American/Alaskan Native
Abstract
The proposed preventative intervention study addresses three of the four MCHB Strategic Research Issues. Specifically, the study addresses efforts to eliminate health barriers and disparities, improve clinical standard of care thus improving services and systems to assure quality of care, and promote the healthy development of MCH populations by evaluating a novel approach to prevent a serious and potentially life-threatening dental disease in young high risk children. Tooth decay (dental caries) is preventable yet American Indians still have extremely high rates. The Healthy People 2010 midcourse review reported that the rate of tooth decay in children 2 to 4 years of age is rising and because of inequities in access and the heavy workloads and shortages of dentists in public service, a large proportion of affected children remain untreated. Tooth decay in childhood is serious. Left untreated decay will progress and infect surrounding teeth, tissue, and bone leading to facial cellulitis and avoidable mortality. The childhood tooth decay epidemic has roused the medical communities and pediatricians are incorporating oral health education and topical fluoride interventions into the well-child preventive health visits. Topical fluorides can prevent tooth decay but are not effective enough to control the development and progression of dental caries in high risk children. For many years, researchers have called for the use of combination therapy of topical fluoride and antimicrobials to control decay causing oral pathogens. Combination therapies may prove to be better choices in the battle to control and eliminate tooth decay in high risk children. Povidone (PVP) Iodine is a potent antiseptic active against oral pathogens. Specific Aim: The aim of this proposed study is to determine if combination therapy PVP-Iodine and fluoride varnish is more efficacious in reducing tooth decay in high risk very young children than fluoride varnish alone. Method: This is a two-group, double-blind, randomized, placebo-control trial. The study enrolls 350 children ages 4 to 6 months who attend the Gallup Indian Medical Center (GIMC) Pediatric Clinic; most are Navajo members. Children are randomized to PVP-Iodine solution and fluoride varnish condition or to placebo solution and fluoride varnish (control) condition. PVP-Iodine (or placebo) solution is applied to the teeth of children then wiped-off followed by application of fluoride varnish. Children receive the interventions at their 6, 9, 15, 24-month pediatric well-child visits (standard GIMC schedule) and have their teeth examined between 24 - 30 months of age. The primary outcome is tooth decay (dmft) and is assessed using the ICDAS protocol. Dental examinations are completed by dentists trained and calibrated in the ICDAS. Analysis: The primary analysis is an intention-to-treat comparison of the incidence rate of cavitated carious teeth (score > 5 on the ICDAS scale) between the two treatment groups. The statistical method used is Poisson regression and hypothesis tests and confidence intervals are obtained using an empirical sandwich estimate of the covariance matrix for the Poisson regression coefficients. Stratification variables used in the randomization scheme (e.g., study site and age) are included in all regression models. Implications: If this demonstration and trial are successful, the results will be disseminated and may change clinical standard of care. Success of the intervention would contribute to efforts in reducing oral health disparities and improving the health of children.<< Previous Next >>