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

Periodontal Disease Clinical Trial

Official title:

Trials to Enhance Elders' Teeth and Oral Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004640
• Other study ID #: NIDCR-008
• Secondary ID: R01DE012215
• Status: Completed
• Phase: Phase 3
• First received: September 17, 1999
• Last updated: June 19, 2012
• Start date: May 1998
• Est. completion date: October 2008

Study information

• Verified date: June 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1101
• Est. completion date: October 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases
• Tooth Decay
• Tooth Loss

Intervention

Drug:
• Chlorhexidine rinse
chlorhexidine solution on tooth loss in low income

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Colgate Palmolive, National Institute of Dental and Craniofacial Research (NIDCR)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regular rinsing with chlorhexidine is effective method for reducing the incidence of tooth loss in low income older adults.		five years of regular rinsing	No