TRIALS TO ENHANCE ELDERS TOOTH/ORAL HEALTH (TEETH)

University Of Washington, Seattle WA

Investigators

Linked publications & trials

Abstract

DESCRIPTION: This study is a collaborative effort between the University of Washington (UW), the coordinating center, and the University of British Columbia (UBC). The main purpose of this five-year, randomized, clinical trial is to test the efficacy of a chlorhexidine and fluoride rinse intervention to reduce tooth-mortality in an elderly population with past oral disease and a poor history of regular dental care. The sample will consist of 900 community dwelling adults, 600 from Seattle and 300 from Vancouver, ages 60-75 at baseline, who have between four and 24 teeth, have not had a dental visit in the last two years, and a score of at least 60 (of 100) on an oral-self-efficacy scale. At each site, participants will be randomized into two groups. In the treatment group, subjects will use fluoride rinse every morning, chlorhexidine every evening for one month followed by weekly chlorhexidine use for five months. The cycle will be repeated every six months for a total of five years. The control group will be given placebo solutions for the fluoride and chlorhexidine products for morning and evening rinsing. The final endpoint is tooth loss determined by clinical exam, comparison of initial and final panoramic radiographs, and information collected from the participants" own dentists of record. Project dentists will not be performing the extractions or dental treatment. Panoramic radiographs, cleanings and scalings will be provided at baseline, and esthetic cleanings in subsequent years. Yearly exams and interviews will be conducted. A secondary aim is to assess the validity of surrogate endpoints (probing pocket depth, loss of attachment, root and coronal caries) compared to tooth loss. An ancillary objective is to determine the impact of ethnicity, intervention site, self-efficacy, and dentist variability on treatment outcomes.