Xylitol Adult Caries Trial (X-ACT)--Study Chair application

木糖醇成人龋齿试验（X-ACT）--研究椅申请

• 批准号: 7190633
• 负责人: JAMES D BADER
• 金额: $ 10.84万
• 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/7190633
• 关键词: clinical research; experience; placebos; prevention; root

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 Study Chair application from the University of North Carolina at Chapel Hill is part of the coordinated set of applications comprising the X-ACT study. Accompanying this application are applications from the Data Coordinating Center and three 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）：成人的龋齿发病率高于儿童。美国疾病控制和预防中心以及美国国立卫生研究院关于龋齿的共识发展会议最近提出的建议，呼吁在龋齿活跃的成年人中试验预防龋齿的方法。对于成人防龋方法的有效性知之甚少，特别是对于患龋病风险较高的成人。该提案描述了一项针对龋齿活跃成年人预防龋齿的干预措施的临床试验，该试验响应了疾病预防控制中心和共识会议的建议。 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中冠龋和根龋发生率方面的有效性。参与者将是 750 名当前或近期患有龋齿的成年人（25-75 岁），他们是北卡罗来纳州教堂山三个临床中心之一的牙科学校患者；阿拉巴马州伯明翰；和德克萨斯州圣安东尼奥市。 这种干预措施正在接受测试，因为它代表了一种潜在有效的龋齿预防方法，很可能被牙科医生采用作为其龋齿活跃患者的“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诊所中接受龋齿预防治疗的机会不足。 北卡罗来纳大学教堂山分校的这份研究主席申请是组成 X-ACT 研究的协调申请集的一部分。随附此申请的是数据协调中心和三个临床中心的申请。程序手册作为本研究主席申请的附录。 与公共卫生的相关性：蛀牙对许多成年人来说是一个严重的问题。关于预防成人蛀牙的方法的研究很少。这项研究将测试每天服用数次的含片对易患蛀牙的成年人预防蛀牙的效果。