A Brief Dental Office Intervention With Tobacco Quitline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Brief Dental Office Intervention With Tobacco Quitline|
- Point prevalence tobacco abstinence at 3 and 6 months
- Feasibility of recruiting patients into a dental quitline
|Study Start Date:||February 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
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:
- To design and refine preconceived models of training format, study implementation, and intervention through focus groups with dentists and dental hygienists.
- To define and refine study implementation, the referral process, recruitment, and data collection strategies and protocols through the sequential engagement of dental practices in active patient enrollment in a nonrandomized feasibility testing process.
- To develop a working Manual of Procedures (MOP) for a future Phase III clinical trial.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273156
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jon O. Ebbert, M.D.||Mayo Clinic|