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"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
This study is ongoing, but not recruiting participants.
First Received: September 17, 1999   Last Updated: July 15, 2008   History of Changes
Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator: Colgate Palmolive
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00004640
  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 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

Resource links provided by NLM:


Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

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
Estimated Study Completion Date: October 2008
Estimated 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
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
Colgate Palmolive
  More Information

No publications provided

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     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
Aging
Elderly
Periodontal Disease
Dental Caries
Fluoride
Antibacterial rinse
Chlorhexidine
Tooth Mortality

Additional relevant MeSH terms:
Mouth Diseases
Tooth Diseases
Anti-Infective Agents
Chlorhexidine
Dental Caries
Tooth Demineralization
Pharmacologic Actions
Anti-Infective Agents, Local
Disinfectants
Periodontal Diseases
Chlorhexidine gluconate
Therapeutic Uses
Stomatognathic Diseases
Dermatologic Agents
Tooth Loss

ClinicalTrials.gov processed this record on November 09, 2009