NCT01846910

Brief Summary

The objectives of this study are:

  1. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

4.8 years

First QC Date

April 30, 2013

Last Update Submit

October 25, 2016

Conditions

Keywords

Cessation

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation

    1-year abstinence from tobacco use, biochemically verified by carbon monoxide breath test

    1-year

Study Arms (2)

Motivational Counseling

ACTIVE COMPARATOR

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

Tooth Whitening Incentive

EXPERIMENTAL

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 WhiteningBehavioral: Motivational Counseling

Interventions

Tooth WhiteningBEHAVIORAL

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

Also known as: Extrinsic vital bleaching
Tooth Whitening Incentive

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.

Also known as: Motivational Interviewing
Motivational CounselingTooth Whitening Incentive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • minors
  • those unable to provide own consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Access Downtown Dental Clinic

Winnipeg, Manitoba, R3B 0L8, Canada

RECRUITING

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Tooth BleachingMotivational Interviewing

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Esthetics, DentalDentistryDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Douglas J Brothwell, DMD MSc

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doug J Brothwell, DMD MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean (Academic)

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 6, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations