Wednesday, April 24, 2024
4/24/2024
Severe Early Childhood Caries (S-ECC) is difficult to treat effectively and has an alarming and distressing tendency to recur following treatment. S-ECC is a particularly acute form of early childhood caries (ECC) that is characterized by an overwhelming caries-promoting microbial challenge, including Mutans Streptococci (MS) and Lactobacilli (LB). The standard of care for ECC/S-ECC revolves around treatment in a surgical operating suite under general anesthesia, followed by application of 5% topical fluoride varnish, family counseling regarding feeding behaviors and oral hygiene instruction. Clinical studies demonstrate approximately 40% of children treated for S-ECC will develop new caries lesions within 12 months after dental surgery. Reducing cariogenic oral microbiota with a topical anti-microbial agent is a potential approach to reduction of recurrent disease in young children with S-ECC. Recent studies have shown that 10% povidone iodine (polyvinylpyrrolidone-iodine, 10% PVPI) appears promising in preventing dental caries in young children. A meta- analysis of antimicrobial interventions and the oral microbiota associated with ECC highlight the paucity of high- quality randomized controlled trials on the efficacy of antimicrobial agents, including PVPI. The data from the National Health and Nutritional Examination Survey (NHANES 2011-2014) indicates that the prevalence of ECC in US preschool children is 24% and ranges between 11% and 72%. The clinical, social and public health impact of ECC/S-ECC is underscored by its association with increased risk of new caries lesions in the primary dentition, a higher risk of caries onset in the permanent dentition, hospitalizations, emergency room visits, high treatment costs, lost school days, diminished ability to learn and a profound impact on a child’s quality of life. The primary objective of this UG3/UH3 application is to assess the efficacy of 10% PVPI in children with S-ECC to prevent, in part or in whole, new cavitated caries lesions that require surgical intervention after oral rehabilitation. The Specific Aims are: 1 (UG3): to finalize the study protocol, develop the Manual of Procedures (MOP), finalize quality management and data management plans, finalize study case report forms (CRFs) and set-up data management system; 2 (UH3): to conduct a single center randomized, double-blind, placebo- controlled Phase II trial (RCT) to evaluate the efficacy of topical 10% PVPI to prevent new cavitated caries lesions when applied to the teeth of children with S-ECC following oral rehabilitation; 3 (UH3): to measure severity and incidence of new dental caries in children with S-ECC following oral rehabilitation who are receiving quarterly topical 10% PVPI; 4 (UH3): to assess the effect of topical 10% PVPI on diversity and composition of oral microbiota, including cariogenic MS, LB and Candida species to better understand the mechanism of action of 10% PVPI on the oral microbiome. The primary outcome will be time from randomization until cavitated carious lesion (ICDAS code 3) is first detected post-surgery. Caries increment will be measured with the International Caries Detection and Assessment System (ICDAS). The approved FDA IND for this trial is #108961.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
