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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01846910
• Other study ID #: H2013:118
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2013
• Last updated: October 25, 2016
• Start date: October 2013
• Est. completion date: August 2019

Study information

• Verified date: October 2016
• Source: University of Manitoba
• Contact: Doug J Brothwell, DMD MSc
• Phone: 204-977-5654
• Email: Doug.Brothwell[@]ad.umanitoba.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: August 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• current smoker

• dental clinic patient

• interested in quitting smoking

Exclusion Criteria:

• minors

• those unable to provide own consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

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
• 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.

Locations

Country	Name	City	State
Canada	Access Downtown Dental Clinic	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation	1-year abstinence from tobacco use, biochemically verified by carbon monoxide breath test	1-year	No