Planning Grant for Xylitol Trial in Caries-Active Adults

描述（由申请人提供）：本提案描述了一项用于预防龋齿活跃成年人龋齿干预的临床试验的计划拨款。关于成年人预防龋齿方法的有效性的信息很少，而且几乎没有关于预防最有可能出现龋齿损害的成年人的信息。最近来自疾病控制中心和美国国立卫生研究院龋齿共识发展会议的建议都呼吁在龋齿活跃的成年人中进行龋齿预防方法的试验。要求规划赠款的主要目的是为拟议的试验编制一份程序手册。此外，规划期间将允许改进参与人员征聘、最大限度地提高和评估遵守情况以及分析龋齿增量数据的计划办法。规划期为两年，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一个为期三年，双中心试验安慰剂对照随机临床试验。干预措施是每天服用木糖醇含片。参与者将是成年人（25岁以上），目前或最近有龋齿病变，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有效的预防龋齿方法，牙科医生很有可能将其作为龋齿活跃患者的“附加”预防龋齿方法，目前的数据表明，龋齿活跃患者在牙科实践中可能没有充分接触到预防龋齿治疗。

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.