Expired Study
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Seattle, Washington 98195


Purpose:

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 summary:

"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


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


Study is Available At:


Original ID:

NIDCR-008


NCT ID:

NCT00004640


Secondary ID:

R01DE012215


Study Acronym:


Brief Title:

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


Official Title:

Trials to Enhance Elders' Teeth and Oral Health


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Washington


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

1101


Enrollment Type:

Anticipated


Study Dates

Start Date:May 1998
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 19, 2012
First Received Date:September 17, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Chlorhexidine rinse
Description:chlorhexidine solution on tooth loss in low income

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Washington
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Dental and Craniofacial Research (NIDCR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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