Improving Clinical Outcomes for Early Chilhood Caries

点击翻译按钮获取中文摘要

DESCRIPTION (provided by applicant): Early Childhood Caries (ECC) continues to be a public health care problem that affects babies and young pre-school children world wide. The current clinical standard of care ignores the concept that ECC is an infectious disease that is characterized by an overwhelming mutans streptococci (MS) infection and decay promoting feeding behaviors. Treatment is usually restricted to removal and restoration of carious teeth coupled with counseling regarding decay promoting feeding behaviors. Dental surgery has minimal impact on oral MS reservoirs and counseling regarding feeding habits has had minimal success. Not surprisingly, approximately 40% of children treated for ECC under general anesthesia relapse with new carious lesions within 6-12 months post treatment. Improved clinical outcomes for treatment of ECC are likely to be realized through treatment strategies that focus the infectious aspect of this disease. Suppressing oral MS reservoirs with an anti-microbial agent is a promising approach. In this regard, 10% povidone iodine is approved as a presurgical disinfectant to the skin and mucous membranes of children and preliminary data indicates that it has prolonged suppressive effects on oral MS populations even in the setting of ECC. Accordingly, the prospect of developing a Phase III clinical trial to test the efficacy of topical application of 10% povidone iodine in improving clinical outcomes for children treated for ECC is most attractive. However, prior to developing a Phase III clinical trial, gathering additional preliminary data are warranted. In this regard, response to dose data are required to establish the proper doing schedule for 10% povidone iodine and strategies need to be developed to enhance subject retention in a Phase III clinical trial. On this basis, this research proposal plans to: 1) establish a dosing schedule for the dental application of the lO% povidone iodine solution and 2) develop retention strategies that will enhance subject retention in a Phase III clinical trial.