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

NCT ID: NCT00004640

Last Updated: 2012-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31
• Study Completion Date: 2008-10-31

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

Conditions

Tooth Loss; Periodontal Disease; Tooth Decay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Interventions

Chlorhexidine rinse

chlorhexidine solution on tooth loss in low income

Intervention Type: DRUG

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Washington

Seattle, Washington, United States

University of British Columbia

Vancouver, British Columbia, Canada

Countries

United States; Canada

Other Identifiers

R01DE012215

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDCR-008

Identifier Type: -

Identifier Source: org_study_id