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OpenTrials
Completed

NCT Number: NCT00273156

A Brief Dental Office Intervention With Tobacco Quitline

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone Quitline

Behavioral

Primary outcomes

  1. Point prevalence tobacco abstinence at 3 and 6 months

Secondary outcomes

  1. Feasibility of recruiting patients into a dental quitline

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 9, 2006
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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