Sugar Sweetened Beverages and Recurrent Severe Early Childhood Caries

University Of Washington, Seattle WA

Investigators

Abstract

DESCRIPTION (provided by applicant): Treatment of young children with Severe Early Childhood Caries (S-ECC) increasingly involves dental treatment under General Anesthesia (GA) due to lack of child cooperation in dental office settings. However, this approach does not control the disease and clinical outcomes are poor with most children developing new caries lesions within two years and some even necessitating retreatment under GA. Increasing disease-free survival time for these children would permit the child to acquire the social and self management skills to cope with in-office dental treatment, avoiding another traumatic and costly treatment episode under GA. Sugars, and particularly extrinsic sugars as those contained in Sugar Sweetened Beverages (SSBs), have been implicated as a major cause of S-ECC, yet trials of efficacious and effective dietary interventions are lacking. The objective of this R34 Clinical Trial Planning Grant is to design a Phase II RCT to assess the efficacy of an environmental dietary and behavioral change intervention, compared with the standard of care, on increasing caries-free survival time in children with S-ECC after dental treatment under GA. The experimental intervention consists of home delivery of fluoridated plain water in attractive bottles in combination with parental dietary counseling aimed to reduce SSB consumption and increase water intake. It is based on socioecological and behavior control theories (model of familial approach) to introduce new familial norms through making changes within the home environment, parental role-modeling, and increasing knowledge related to healthy eating. The primary outcome is time to relapse of dental caries during the 2-year follow up. The Specific Aims are to: 1) Develop and write the RCT clinical protocol using the NIDCR Interventional Clinical Protocol Template. 2) Coordinate IRB review and approval of the study protocol, associated consent documents and recruitment materials as required by the University of Washington (UW) and NIDCR. 3) Develop a plan for clinical monitoring to ensure fidelity of study procedures. 4) Write the Manual of Procedures (MOP) including the content, delivery, and monitoring of the intervention and its quality management (Standard Operating Procedures (SOP) The trial addresses Healthy People 2020 goals (OH-1, OH-2) and NIDCR strategic plan objectives (I-2, II-3, III- 1, IV-1, IV-2), including to reduce dental caries in primary teeth and o eliminate disparities in oral health. It is also complementary to requirements under the federal Healthy Hunger-Free Kids Act of 2010 for free drinking water in schools and the First Lady's initiative Let's Move! This is a project of the University of Washington Northwest Center to Reduce Oral Health Disparities in collaboration with UW Center for Pediatric Dentistry, UW Center for Public Health Nutrition and UW Institute for Translational Health Sciences (ITHS).