"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
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Purpose
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 |
|---|---|---|
|
Tooth Loss Periodontal Disease Tooth Decay |
Drug: Chlorhexidine rinse |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Trials to Enhance Elders' Teeth and Oral Health |
- regular rinsing with chlorhexidine is effective method for reducing the incidence of tooth loss in low income older adults. [ Time Frame: five years of regular rinsing ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1101 |
| Study Start Date: | May 1998 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
-
Drug: Chlorhexidine rinse
"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
Eligibility| Ages Eligible for Study: | 60 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age at entry 60-75
- Four or more natural teeth
- No preventive dental visits in the past 18 months
- Scores > or = 60 on a measure of oral health self-efficacy (max possible=100)
- willing to participate in a five-year study
- willing to use rinses on a prescribed regimen and to return for yearly cleaning and exam appointments.
Exclusion criteria:
- Not having a phone at home for follow-up calls
Contacts and Locations| 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 | |
More Information
No publications provided
| Responsible Party: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00004640 History of Changes |
| Other Study ID Numbers: | NIDCR-008, R01DE012215, R01DE12215 |
| Study First Received: | September 17, 1999 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Washington:
|
Aging Elderly Periodontal Disease Dental Caries |
Fluoride Antibacterial rinse Chlorhexidine Tooth Mortality |
Additional relevant MeSH terms:
|
Dental Caries Periodontal Diseases Tooth Loss Tooth Demineralization Tooth Diseases Stomatognathic Diseases Mouth Diseases Chlorhexidine |
Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013