|
"Clinical Trials to Enhance Elders' Oral Health" ("TEETH") Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on "Clinical Trials to Enhance Elders' Oral Health" ("TEETH") conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. "Clinical Trials to Enhance Elders' Oral Health" ("TEETH") Clinical research trials and "Clinical Trials to Enhance Elders' Oral Health" ("TEETH") healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including "Clinical Trials to Enhance Elders' Oral Health" ("TEETH"). "Clinical Trials to Enhance Elders' Oral Health" ("TEETH") Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a "Clinical Trials to Enhance Elders' Oral Health" ("TEETH") clinical trial. Participants typically obtain the most effective healthcare available for their "Clinical Trials to Enhance Elders' Oral Health" ("TEETH") condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > """ Clinical Trials Conditions > "Clinical Trials to Enhance Elders' Oral Health" ("TEETH")  "Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
For Condition: Tooth decay,Periodontal Disease,Tooth Loss
Status: No longer recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) , Colgate Palmolive
Synopsis: 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.
Details: "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
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 60 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 1101
Location and Contact Information:
University of Washington
Seattle, Washington, 98195-7134
United States
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Canada
Additional Information:
Study ID Numbers: NIDCR-008; R01DE12215
Study Start Date: May 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004640
Other Tooth Decay Studies:
1. "Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
Related Studies:
Other Tooth decay Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
|
|
|
|
|
|
|
|
