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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DE018038-05
Application #
7886779
Study Section
Special Emphasis Panel (ZDE1-YL (75))
Program Officer
Atkinson, Jane C
Project Start
2006-09-22
Project End
2012-07-31
Budget Start
2010-08-01
Budget End
2012-07-31
Support Year
5
Fiscal Year
2010
Total Cost
$113,186
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Dentistry
Type
Schools of Dentistry
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Ritter, André V; Preisser, John S; Puranik, Chaitanya P et al. (2016) A Predictive Model for Root Caries Incidence. Caries Res 50:271-8
Brown, John P; Amaechi, Bennett T; Bader, James D et al. (2015) The dynamic behavior of the early dental caries lesion in caries-active adults and implications. Community Dent Oral Epidemiol 43:208-16
Brown, John P; Amaechi, Bennett T; Bader, James D et al. (2014) Visual scoring of non cavitated caries lesions and clinical trial efficiency, testing xylitol in caries-active adults. Community Dent Oral Epidemiol 42:271-8
Ritter, A V; Bader, J D; Leo, M C et al. (2013) Tooth-surface-specific effects of xylitol: randomized trial results. J Dent Res 92:512-7
Bader, James D; Vollmer, William M; Shugars, Daniel A et al. (2013) Results from the Xylitol for Adult Caries Trial (X-ACT). J Am Dent Assoc 144:21-30
Ritter, André V; Preisser, John S; Chung, Yunro et al. (2012) Risk indicators for the presence and extent of root caries among caries-active adults enrolled in the Xylitol for Adult Caries Trial (X-ACT). Clin Oral Investig 16:1647-57
Banting, David W; Amaechi, Bennett T; Bader, James D et al. (2011) Examiner training and reliability in two randomized clinical trials of adult dental caries. J Public Health Dent 71:335-44
Bader, James D; Robinson, Debbie S; Gilbert, Gregg H et al. (2010) Four ""lessons learned"" while implementing a multi-site caries prevention trial. J Public Health Dent 70:171-5
Bader, James D; Shugars, Daniel A; Vollmer, William M et al. (2010) Design of the xylitol for adult caries trial (X-ACT). BMC Oral Health 10:22