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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01846910
Recruitment Status : Recruiting
First Posted : May 6, 2013
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Smoking Smoking Cessation Behavioral: Tooth Whitening Behavioral: Motivational Counseling

Detailed Description:
See above

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prepare to Quit - A Randomized Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting
Study Start Date : October 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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: 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 Name: Extrinsic vital bleaching
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 Name: Motivational Interviewing


Outcome Measures

Primary Outcome Measures :
  1. Smoking Cessation [ Time Frame: 1-year ]
    1-year abstinence from tobacco use, biochemically verified by carbon monoxide breath test


Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • minors
  • those unable to provide own consent
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): NCT01846910


Contacts
Contact: Doug J Brothwell, DMD MSc 204-977-5654 Doug.Brothwell@ad.umanitoba.ca

Locations
Canada, Manitoba
Access Downtown Dental Clinic Recruiting
Winnipeg, Manitoba, Canada, R3B 0L8
Contact: Douglas J Brothwell, DMD MSc    204-977-5654    Doug.Brothwell@ad.umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Douglas J Brothwell, DMD MSc University of Manitoba
More Information

Responsible Party: Dr. Douglas James Brothwell, Associate Dean (Academic), University of Manitoba
ClinicalTrials.gov Identifier: NCT01846910     History of Changes
Other Study ID Numbers: H2013:118
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Keywords provided by Dr. Douglas James Brothwell, University of Manitoba:
Cessation