A Brief Dental Office Intervention With Tobacco Quitline
Primary Purpose
Smoking, Nicotine Dependence
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telephone quitline
Sponsored by
About this trial
This is an interventional treatment trial for Smoking
Eligibility 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.
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Point prevalence tobacco abstinence at 3 and 6 months
Secondary Outcome Measures
Feasibility of recruiting patients into a dental quitline
Full Information
NCT ID
NCT00273156
First Posted
January 6, 2006
Last Updated
April 22, 2013
Sponsor
Mayo Clinic
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT00273156
Brief Title
A Brief Dental Office Intervention With Tobacco Quitline
Official Title
A Brief Dental Office Intervention With Tobacco Quitline
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
5. Study Description
Brief Summary
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Nicotine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Telephone quitline
Primary Outcome Measure Information:
Title
Point prevalence tobacco abstinence at 3 and 6 months
Secondary Outcome Measure Information:
Title
Feasibility of recruiting patients into a dental quitline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon O. Ebbert, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33605440
Citation
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Results Reference
derived
Learn more about this trial
A Brief Dental Office Intervention With Tobacco Quitline
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