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

June 19, 2012 updated by: University of Washington

Trials to Enhance Elders' Teeth and Oral Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

1101

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • University of British Columbia
  • United States
    • Washington
      • Seattle, Washington, United States, 98195-7134
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
five years of regular rinsing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)
Colgate Palmolive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 17, 1999

First Submitted That Met QC Criteria

September 17, 1999

First Posted (Estimate)

September 20, 1999

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCR-008
  • R01DE012215 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tooth Loss

Clinical Trials on Chlorhexidine rinse

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe