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Trials to Enhance Elders Teeth and Oral Health ("TEETH" Study)
PI: H. Asuman Kiyak, Ph.D., Professor, Oral & Maxillofacial Surgery, School of Dentistry, University of Washington
Specific Aims: The "TEETH" Study is a pivotal double-blind study whose primary objective is to determine the effect of chlorhexidine rinse on tooth mortality in community-dwelling older people who are at high risk for oral disease morbidity. A secondary aim is to test the validity of commonly used surrogate endpoints in dental research. "TEETH" is a collaborative study between the University of Washington (UW) and the University of British Columbia (UBC); it is based on a recently completed exploratory study also conducted by this research team. That study found that chlorhexidine in combination with any rigorous home care regimen was effective in reducing caries and periodontal disease. The intent is to enroll 1100 subjects into the study.
During the 1999 IADR annual meeting in Vancouver, the P.I. organized a symposium entitled, "Challenges in Conducting Clinical Trials with Older Adults." Two of the papers presented at the symposium were based on this clinical trial; one on issues of selecting appropriate endpoints (by Dr. Philippe Hujoel) and the other on successful recruitment methods for clinical trials (presented by Dr. Kiyak). This material is currently being prepared for publication.
This study will be the first randomized clinical trial in dental research to assess an outcome of tangible patient benefit (i.e. prevention of all-cause tooth mortality), with a large sample of older adults. Definitive evidence regarding the safety and efficacy of a simple rinse regimen has the potential to have a significant impact on the worldwide utilization of this low-cost, home-based intervention. In addition, TEETH provides the opportunity to assess a fundamental assumption underlying most of the current dental clinical research: i.e. do surrogate measures of dental disease provide valid information regarding an outcome of tangible patient benefit (tooth mortality)?
[Caries and Restorative Dentistry]
[Temporomandibular Joint Studies]