Xylitol Adult Caries Trial (X-ACT)--UNC Clinical Center

描述(申请人提供)：成人的龋齿发病率高于儿童。疾病控制和预防中心最近提出的建议和NIH关于龋齿的共识发展会议呼吁在龋齿活跃的成年人中试验预防龋齿的方法。人们对成人，特别是那些患龋病风险较高的成年人的防龋方法的有效性知之甚少。这项建议描述了一项干预措施的临床试验，以预防龋病活跃的成年人的龋齿，这是对疾控中心和共识会议的建议的回应。 木糖醇成人龋齿试验(X-ACT)是一项为期三年、多中心、随机、安慰剂对照的双盲研究，目的是评估木糖醇含片在降低龋齿活跃成年人的冠面和根面龋齿发病率方面的有效性。参与者将是750名患有当前或最近龋损的成年人(年龄在25-75岁之间)，他们是北卡罗来纳州教堂山、阿拉巴马州伯明翰和德克萨斯州圣安东尼奥三个临床中心之一的牙科学校患者。 这一干预措施正在测试中，因为它代表了一种潜在的有效的龋齿预防方法，很有可能被牙科医生作为他们的龋齿活跃患者的另一种防龋方法。采用干预措施的可能性是一个重要的考虑因素，因为目前的数据表明，龋病活跃的成年人在牙科实践中没有充分接触到龋病预防治疗。 这项来自北卡罗来纳大学教堂山分校(UNC)牙科学院的临床中心申请是X-ACT研究中协调应用集的一部分。伴随这一申请的是来自研究主席、数据协调中心和其他两个临床中心的申请。程序手册作为本研究教席申请的附录。 与公共健康相关：龋齿对许多成年人来说是一个严重的问题。在预防成年人龋齿的方法上，几乎没有进行过研究。这项研究将测试一天服用几次的含片在预防容易龋齿的成年人中的效果如何。

DESCRIPTION (provided by applicant): Dental caries incidence is higher in adults than children. Recent recommendations from the Centers for Disease Control and Prevention and an NIH Consensus Development Conference on dental caries call for trials of caries prevention methods in caries-active adults. Little is known about the effectiveness of caries prevention methods in adults, especially for adults who are at elevated risk for developing caries lesions. This proposal describes a clinical trial of an intervention to prevent dental caries in caries-active adults that is responsive to the CDC and Consensus Conference recommendations. The Xylitol for Adult Caries Trial (X-ACT) is a three-year, multi-center, randomized, placebo-controlled, double-blind study to assess the effectiveness of xylitol lozenges in reducing the incidence of coronal and root caries in caries-active adults. Participants will be 750 adults (ages 25-75) with current or recent caries lesions who are dental school patients at one of the three clinical centers in Chapel Hill, North Carolina; Birmingham, Alabama; and San Antonio, Texas. This intervention is being tested because it represents a potentially effective caries prevention method with a high likelihood of adoption by dental practitioners as an "add on" caries preventive method for their cariesactive patients. The potential for adoption of the intervention is an important consideration, because current data suggest that caries-active adults are underexposed to caries-preventive treatment in dental practices. This Clinical Center application from the University of North Carolina at Chapel Hill (UNC) School of Dentistry is part of the coordinated set of applications comprising the X-ACT study. Accompanying this application are applications from the Study Chair, Data Coordinating Center, and two other clinical centers. A Manual of Procedures appears as an appendix to this Study Chair application. Relevance to public health: Tooth decay is a serious problem for many adults. Little research has been done on methods to prevent tooth decay in adults. This study would test how well a lozenge to be taken several times a day works to prevent tooth decay in adults who are prone to tooth decay.