Prepare to Quit - A Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting

October 25, 2016 updated by: Dr. Douglas James Brothwell, University of Manitoba

Prepare to Quit - A Randomized Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting

The objectives of this study are:

  1. To determine the effect that an intensive, community dental clinic centered, stop-smoking program using a motivational interviewing approach has upon cessation rates for interested, smoking inner-city dental patients.
  2. To determine the effect that providing a tooth whitening incentive, in a community dental clinic stop-smoking program, has upon cessation rates for interested, smoking inner-city dental patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

See above

Study Type

Interventional

Enrollment (Anticipated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3B 0L8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • current smoker
  • dental clinic patient
  • interested in quitting smoking

Exclusion Criteria:

  • minors
  • those unable to provide own consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Motivational Counseling
The extended counseling group will receive one to three, 45-minute individual motivational counseling sessions using a motivational interviewing approach to Express empathy, Develop discrepancy, Roll with resistance, and Support self-efficacy.
Behavioral: Motivational Counseling
Normally three counseling sessions. Session #1: Introductions; discuss habits, feelings, pros and cons of smoking; degree of addiction; previous quit attempts and relapse; reinforce patient confidence; open-ended questions to illicit self-efficacy; homework includes Pack-Track and Why Test. Session #2: Discuss smoking patterns, triggers, and risk situations; discuss methods to resist triggers, need for medications; prepare environment and back-up plan; discuss quit date; homework to review self-help workbook. Session #3: Reinforce previous concepts; review resistance plan; discuss and arrange pharmaceutical cessation aids; set quit date; homework to finalize all self/home preparations; offer tooth polishing on quit date; follow-up by telephone or appointment.
Other Names:
  • Motivational Interviewing
Experimental: Tooth Whitening Incentive
The tooth whitening group will receive all of the interventions previously described for the Motivational Counseling Group, and as an extra incentive against relapse, will also be offered complimentary tooth whitening procedures if biochemically verified as tobacco-free by Carbon Monoxide monitor (bleaching at 3-weeks, whitening strips at 3-months, and whitening touch-up at 1 year).
Behavioral: Motivational Counseling
Normally three counseling sessions. Session #1: Introductions; discuss habits, feelings, pros and cons of smoking; degree of addiction; previous quit attempts and relapse; reinforce patient confidence; open-ended questions to illicit self-efficacy; homework includes Pack-Track and Why Test. Session #2: Discuss smoking patterns, triggers, and risk situations; discuss methods to resist triggers, need for medications; prepare environment and back-up plan; discuss quit date; homework to review self-help workbook. Session #3: Reinforce previous concepts; review resistance plan; discuss and arrange pharmaceutical cessation aids; set quit date; homework to finalize all self/home preparations; offer tooth polishing on quit date; follow-up by telephone or appointment.
Other Names:
  • Motivational Interviewing
Behavioral: Tooth Whitening
1. A dental check-up will ensure the absence of contraindications to tooth whitening (cavities, soft tissue pathology, severe periodontitis) 2. Removal of calculus, plaque, or stains with a dental polishing 3. Treatment time is approximately 1 hour total4. Lips are retracted, tongue protector is placed and protective eyewear used 5. Saliva is suctioned and teeth are air dried 6. A liquid rubber dam material is applied to protect gums and cured by visible light. 7. The bleaching material is placed on the enamel surface of the involved teeth and is replaced if drying occurs 8. After 15 minutes, the bleach is suctioned, mouth rinsed and process repeated 9. Three to four applications are typically used
Other Names:
  • Extrinsic vital bleaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Cessation
Time Frame: 1-year
1-year abstinence from tobacco use, biochemically verified by carbon monoxide breath test
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Douglas J Brothwell, DMD MSc, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 6, 2013

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H2013:118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking

Clinical Trials on Motivational Counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe