Planning Grant for Xylitol Trial in Caries-Active Adults

描述（由申请人提供）：本提案描述了一项计划拨款，用于预防龋齿活跃成年人龋齿的干预临床试验。关于成年人龋齿预防方法的有效性的信息很少，并且几乎没有关于最有可能经历龋齿病变的成年人的预防的信息。疾病控制中心和NIH关于龋齿的共识发展会议最近提出的建议都要求在龋齿活跃的成年人中进行龋齿预防方法的试验。 请批规划补助金主要是为拟议的审判编写一份《程序手册》。此外，规划期将允许在计划的参与者招募方法，以最大限度地提高和评估遵守，并分析龋齿增量数据的完善。计划期为两年，计划活动涉及来自拟定临床中心和数据协调中心的人员。拟议的临床试验是一项为期三年的双中心安慰剂对照随机临床试验。干预措施是每天使用木糖醇含片。参与者将是目前或近期患有龋齿病变的成年人（25岁以上），他们是其中一个临床中心的患者。这种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，牙科医生采用这种方法作为龋齿活跃患者的“附加”龋齿预防方法的可能性相当高，目前的数据表明，这一群体在牙科实践中可能对龋齿预防治疗暴露不足。

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.