Completed

Trials to Enhance Elders' Teeth and Oral Health

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What is being tested

Chlorhexidine rinse

Drug
Who is being recruted

Stomatognathic Diseases+4

+ Mouth Diseases

+ Tooth Diseases

From 60 to 75 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: May 1998
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: June 20, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1998

Actual date on which the first participant was enrolled.

"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

NCT00004640
Principal SponsorUniversity of Washington
Last updated: June 20, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1101 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesTooth DiseasesTooth DemineralizationDental CariesPeriodontal DiseasesTooth Loss

Criteria

6 inclusion criteria required to participate
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)

Show More Criteria

1 exclusion criteria prevent from participating
Not having a phone at home for follow-up calls

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Washington

Seattle, United StatesOpen University of Washington in Google Maps

University of British Columbia

Vancouver, Canada
Completed2 Study Centers