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

University of Washington

Status and phase

Completed

Phase 3

Conditions

Tooth Loss

Tooth Decay

Periodontal Disease

Treatments

Drug: Chlorhexidine rinse

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00004640

R01DE012215 (U.S. NIH Grant/Contract)

NIDCR-008

Details and patient eligibility

About

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.

Full 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

Enrollment

1,101 estimated patients

Sex

All

Ages

60 to 75 years old

Volunteers

Accepts Healthy Volunteers

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