"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")

This study has been completed.
Sponsor:
Collaborators:
Colgate Palmolive
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00004640
First received: September 17, 1999
Last updated: June 19, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Drug: Chlorhexidine rinse
    chlorhexidine solution on tooth loss in low income
Detailed Description:

"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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004640

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
Sponsors and Collaborators
University of Washington
Colgate Palmolive
  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 July 22, 2014