Trial record 12 of 423 for:    Open Studies | "Smoking"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr. Douglas James Brothwell, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01846910
First received: April 30, 2013
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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 Intervention
Smoking
Smoking Cessation
Behavioral: Tooth Whitening
Behavioral: Motivational Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Smoking Cessation [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    1-year abstinence from tobacco use, biochemically verified by carbon monoxide breath test


Estimated Enrollment: 235
Study Start Date: October 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Brief Cessation

The Brief Cessation group will receive a 3-5 minute service

  1. Ask about smoking status
  2. Advise of the related health risks and need to quit
  3. Assess readiness to quit
  4. Assist to quit using brief advice and referral
  5. Arrange for follow-up based on dental need
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

Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 30, 2013
Last Updated: October 11, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Cessation

Additional relevant MeSH terms:
Smoking
Food Habits
Habits

ClinicalTrials.gov processed this record on July 31, 2014