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

木糖醇成人龋齿试验 (X-ACT)--北卡罗来纳大学临床中心

• 批准号: 7289839
• 负责人: Daniel A Shugars
• 金额: $ 19.68万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-22 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7289839
• 关键词: Adoption; Adult; Age; Alabama; Appendix; Caries prevention; Centers for Disease Control and Prevention (U.S.); Child; Clinical; Clinical Trials; Consensus; Data; Data Coordinating Center; Dental; Dental General Practice; Dental Schools; Dental caries; Double-Blind Method; Effectiveness; Incidence; Intervention; Lesion; Manuals; Methods; NIH Consensus Development Conferences; North Carolina; Participant; Patients; Placebo Control; Preventive; Procedures; Protocols documentation; Public Health; Randomized; Recommendation; Research; Risk; Root Caries; School Dentistry; Testing; Texas; Time; Universities; Work; Xylitol; day; prevent; symposium

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.

描述（由申请人提供）：成年人的龋齿发病率高于儿童。疾病控制和预防中心和NIH关于龋齿的共识发展会议最近建议在龋齿活跃的成年人中进行龋齿预防方法的试验。关于成人龋齿预防方法的有效性知之甚少，特别是对于患龋齿病变风险升高的成人。该提案描述了一项干预措施的临床试验，以预防龋齿活跃的成年人龋齿，这是对CDC和共识会议建议的回应。 木糖醇治疗成人龋齿试验（X-ACT）是一项为期三年、多中心、随机、安慰剂对照、双盲研究，旨在评估木糖醇含片在降低龋齿活跃成人冠状面和根面龋齿发病率方面的有效性。参与者将是750名患有当前或近期龋齿病变的成年人（年龄25-75岁），他们是北卡罗来纳州查佩尔山、亚拉巴马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，很有可能被牙科医生采用，作为其龋齿患者的“附加”龋齿预防方法。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，龋齿活跃的成年人在牙科实践中对龋齿预防治疗的暴露不足。 来自北卡罗来纳州大学查佩尔山（北卡罗来纳州）牙科学院的临床中心申请是组成X-ACT研究的协调申请集的一部分。随附的申请是来自研究主席、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椅应用程序的附录出现。 与公共卫生的相关性：蛀牙是许多成年人面临的严重问题。很少有人研究预防成年人蛀牙的方法。这项研究将测试每天服用几次的含片对预防容易蛀牙的成年人蛀牙的效果如何。