A Brief Dental Office Intervention With Tobacco Quitline

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00273156
First received: January 6, 2006
Last updated: April 22, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Brief Dental Office Intervention With Tobacco Quitline

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00273156

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jon O. Ebbert, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00273156     History of Changes
Other Study ID Numbers: 1225-04
Study First Received: January 6, 2006
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 16, 2014