Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004640
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
1999-09-17
Brief Title:
Clinical Trials to Enhance Elders Oral Health TEETH
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Trials to Enhance Elders Teeth and Oral Health
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 012 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 BC onehalf 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 dentists 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE012215 | NIH | None | httpsreporternihgovquickSearchR01DE012215 |