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A Brief Dental Office Intervention With Tobacco Quitline

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00273156
First Posted: January 9, 2006
Last Update Posted: April 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
Mayo Clinic
  Purpose
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
Smoking Nicotine Dependence Behavioral: Telephone quitline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Brief Dental Office Intervention With Tobacco Quitline

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Point prevalence tobacco abstinence at 3 and 6 months

Secondary Outcome Measures:
  • Feasibility of recruiting patients into a dental quitline

Enrollment: 90
Study Start Date: February 2005
Study Completion Date: December 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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:

  1. To design and refine preconceived models of training format, study implementation, and intervention through focus groups with dentists and dental hygienists.
  2. 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.
  3. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273156


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Jon O. Ebbert, M.D. Mayo Clinic
  More Information

ClinicalTrials.gov Identifier: NCT00273156     History of Changes
Other Study ID Numbers: 1225-04
First Submitted: January 6, 2006
First Posted: January 9, 2006
Last Update Posted: April 23, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders