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Sponsors and Collaborators: |
National Institute of Dental and Craniofacial Research (NIDCR) Colgate Palmolive |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00004640 |
The purpose of this study is to determine if regular rinsing with chlorhexidine is effective as a long-term preventive method for reducing the incidence of tooth loss in low income older adults. The true end-point of the study is tooth loss after five years of regular rinsing with chlorhexidine or a placebo; surrogate endpoints are periodontal disease, root and coronal decay.
Condition | Intervention | Phase |
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Tooth Loss Periodontal Disease Tooth Decay |
Drug: Chlorhexidine rinse |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Trials to Enhance Elders' Teeth and Oral Health |
Estimated Enrollment: | 1101 |
Study Start Date: | May 1998 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
"TEETH" is a double-blinded, randomized clinical trial, supervised by a Data & Safety Monitoring Board, designed to provide unequivocal evidence regarding the impact of regular rinsing 0.12% chlorhexidine solution on tooth loss in low income, community-dwelling older adults who are irregular users of dental services. Of the 1101 subjects enrolled in the study in Seattle, WA and Vancouver, B.C., one/half have been assigned to the active rinse condition; the other half to the placebo rinse which looks and tastes like the chlorhexidine rinse but does not have the active ingredient. Subjects receive two bottles of rinse every six months; the first to be used daily for one month, the second weekly for five months. Reminder calls are designed to help subjects maintain this rinse regimen. Subjects return yearly to research clinics at each participating university, where they are examined by a dentist who is trained in clinical research methodology and calibrated annually. The purpose of these visits is to examine subjects for tooth loss (followed by contacts with extracting dentists to determine the dentist's reasons for extracting the tooth), pocket depth, recession, caries and restorations on root and coronal surfaces. Interviews are also conducted annually with participants to assess health status, health behaviors, and oral health quality of life. A panoramic radiograph was taken at baseline of each subject and is to be done again at the five-year (final) yearly exam. These radiographs are used to confirm tooth loss and possible reasons for extractions
Ages Eligible for Study: | 60 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195-7134 | |
Canada, British Columbia | |
University of British Columbia | |
Vancouver, British Columbia, Canada, V6T 1Z3 |
Responsible Party: | Dr. Asuman Kiyak, M.A., Ph.D. ( Dr. Asuman Kiyak, M.A., Ph.D. ) |
Study ID Numbers: | NIDCR-008, R01DE12215 |
Study First Received: | September 17, 1999 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00004640 |
Health Authority: | United States: Federal Government |
Aging Elderly Periodontal Disease Dental Caries |
Fluoride Antibacterial rinse Chlorhexidine Tooth Mortality |
Mouth Diseases Tooth Diseases Periodontal Diseases Chlorhexidine Chlorhexidine gluconate |
Stomatognathic Diseases Fluorides Tooth Loss Dental Caries |
Anti-Infective Agents Anti-Infective Agents, Local Disinfectants Therapeutic Uses |
Dermatologic Agents Pharmacologic Actions Tooth Demineralization |