Planning Grant for Xylitol Trial in Caries-Active Adults

描述(由申请人提供)：这项提案描述了一项预防龋齿活跃的成年人的干预措施的临床试验的规划拨款。关于成人龋齿预防方法的有效性的信息很少，而且几乎没有关于最有可能经历龋损的成年人的预防信息。疾病控制中心最近的建议和NIH关于龋齿的共识发展会议都呼吁在龋齿活跃的成年人中试验预防龋齿的方法。申请规划赠款的主要目的是为拟议的试验制定一份程序手册。此外，规划期将允许改进参与者招募、最大化和评估遵守情况以及分析龋齿增加数据的计划办法。规划周期为两年，规划活动涉及拟建临床中心和数据协调中心的人员。拟议的临床试验被设想为为期三年的两中心试验，安慰剂对照的随机临床试验。干预措施是每天使用木糖醇含片。参与者将是目前或最近有龋损的成年人(25人)，他们是其中一个临床中心的患者。这一干预措施正在进行测试，因为它代表了一种潜在的有效的龋齿预防方法，有相当高的可能性被牙科医生作为龋病活跃患者的预防龋齿方法，目前的数据表明，在牙科实践中，这一群体可能接触不到防龋治疗。

DESCRIPTION (provided by applicant): This proposal describes a planning grant for a clinical trial of an intervention to prevent dental caries in caries-active adults. Little information is available about the effectiveness of caries prevention methods in adults, and virtually no information exists with respect to prevention among adults who are most likely to experience carious lesions. Recent recommendations from the Centers for Disease Control and an NIH Consensus Development Conference on dental caries both call for trials of caries prevention methods in caries active adults. The planning grant is requested principally to develop a Manual of Procedures for the proposed trial. In addition, the planning period will permit refinements in planned approaches to participant recruitment, to maximizing and assessing adherence, and to analyses of caries increment data. The planning period is two years, and the planning activities involve personnel from both proposed clinical centers and the data coordinating center. The proposed clinical trial is envisioned as a three-year, two-center trial placebo-controlled randomized clinical trial. The intervention is the daily use of xylitol lozenges. Participants will be adults (25+) with current or recent caries lesions who are patients of one of the clinical centers. This intervention is being tested because it represents a potentially effective caries prevention method with a reasonably high likelihood of adoption by dental practitioners as an "add on" caries preventive method for caries-active patients, a group that current data suggests may be underexposed to caries-preventive treatment in dental practices.