Clinical trial NCT00004640: "Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
Official title: Trials to Enhance Elders' Teeth and Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tooth Loss
Periodontal Disease
Tooth Decay
Keywords: Aging
Elderly
Periodontal Disease
Dental Caries
Fluoride
Antibacterial rinse
Chlorhexidine
Tooth Mortality
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Colgate Palmolive
First posted: 1999-09-20
Enrollment: 1101
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: regular rinsing with chlorhexidine is effective method for reducing the incidence of tooth loss in low income older adults.
timeFrame: five years of regular rinsing
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
References: