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"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
This study is ongoing, but not recruiting participants.
Study NCT00004640   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: September 17, 1999   Last Updated: July 15, 2008   History of Changes

September 17, 1999
July 15, 2008
May 1998
May 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00004640 on ClinicalTrials.gov Archive Site
 
 
 
"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
Trials to Enhance Elders' Teeth and Oral Health

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.

"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

Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
  • Tooth Loss
  • Periodontal Disease
  • Tooth Decay
Drug: Chlorhexidine rinse
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1101
October 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
60 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00004640
Dr. Asuman Kiyak, M.A., Ph.D., Dr. Asuman Kiyak, M.A., Ph.D.
NIDCR-008, R01DE12215
National Institute of Dental and Craniofacial Research (NIDCR)
Colgate Palmolive
 
National Institute of Dental and Craniofacial Research (NIDCR)
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP