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Sponsors and Collaborators: |
Mayo Clinic National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00273156 |
The novel and exploratory nature of this intervention relates to the concept of incorporating patient-specific oral health information obtained during a dental hygiene visit into the tobacco quitline counseling. Linking the patient-specific oral health information obtained during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic loop for oral health professionals and make them a focal point for the tobacco use intervention without increasing clinical burden.
Condition | Intervention | Phase |
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Smoking Nicotine Dependence |
Behavioral: Telephone quitline |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Brief Dental Office Intervention With Tobacco Quitline |
Estimated Enrollment: | 90 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | June 2006 |
The overarching hypothesis of this line of research is: A brief office intervention with proactive tobacco quitline counseling incorporating patient-specific oral health information obtained during a dental hygiene visit (intervention) will increase prolonged abstinence rates from cigarette smoking compared to a brief office intervention alone (control) at 3 and 6 months.To test our overarching hypothesis in a Phase III clinical trial, we are first seeking R21 funding through the NIDCR Clinical Pilot Data Grant (PAR-03-043) mechanism. This R21 funding will be used to refine the design of dental clinic staff training, study implementation, and data collection procedures, to optimize the design of the definitive trial, and to test and document recruitment and data collection mechanisms.
The specific aims of this R21 proposal are:
The feasibility study will be conducted through private practice dental clinics surrounding the Mayo Clinic in Rochester, MN. We are planning for a multicenter Phase III clinical trial involving private practice dental clinics in the communities surrounding Rochester, MN, and Indianapolis, IN, in collaboration with the Indiana University Nicotine Dependence Program.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Patients were eligible to participate if they were cigarette smokers, older than the age of 18 years, and presenting to the dentist for routine dental prophylaxis.
Study ID Numbers: | 1225-04 |
Study First Received: | January 6, 2006 |
Last Updated: | August 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00273156 History of Changes |
Health Authority: | United States: Institutional Review Board |
Smoking Mental Disorders Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |
Mental Disorders Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |