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| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 17, 1999 |
| Last Updated Date | July 15, 2008 |
| Start Date ICMJE | May 1998 |
| Estimated Primary Completion Date | May 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00004640 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | "Clinical Trials to Enhance Elders' Oral Health" ("TEETH") |
| Official Title ICMJE | Trials to Enhance Elders' Teeth and Oral Health |
| 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 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 |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Chlorhexidine rinse |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Estimated Enrollment ICMJE | 1101 |
| Estimated Completion Date | October 2008 |
| Estimated Primary Completion Date | May 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
|
| Gender | Both |
| Ages | 60 Years to 75 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Canada |
| Administrative Information | |
| NCT ID ICMJE | NCT00004640 |
| Responsible Party | Dr. Asuman Kiyak, M.A., Ph.D., Dr. Asuman Kiyak, M.A., Ph.D. |
| Study ID Numbers ICMJE | NIDCR-008, R01DE12215 |
| Study Sponsor ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) |
| Collaborators ICMJE | Colgate Palmolive |
| Investigators ICMJE | |
| Information Provided By | National Institute of Dental and Craniofacial Research (NIDCR) |
| Verification Date | July 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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