SmokingNCT01846910
Prepare to Quit - A Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting
A study testing Tooth Whitening and Motivational Counseling in people with Smoking and Smoking Cessation, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Tooth Whitening and Motivational Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- current smoker
- dental clinic patient
- interested in quitting smoking
Who cannot join
- minors
- those unable to provide own consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Access Downtown Dental Clinic
Winnipeg, Manitoba, R3B 0L8
Douglas J Brothwell, DMD MSc, 204-977-5654, Doug.Brothwell@ad.umanitoba.ca
About this study
Official title: Prepare to Quit - A Randomized Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting
The objectives of this study are:
- 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.
- 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.
Read the detailed description
See above
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Tooth Whitening, Motivational Counseling
- Keywords
- Cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth WhiteningBehavioural
Also called Extrinsic vital bleaching
- 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 CounselingBehavioural
Also called Motivational Interviewing
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Tooth Whitening; Behavioral: Motivational Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
1-year abstinence from tobacco use, biochemically verified by carbon monoxide breath test
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Douglas James Brothwell, University of Manitoba
- Investigators
- Douglas J Brothwell, DMD MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846910
- Sponsor's protocol ID
- H2013:118
- Status last verified
- Oct 2016
- First submitted
- 30 Apr 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepare to Quit - A Randomized Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting
- ClinicalTrials.gov ID
- NCT01846910
- Acronym / sponsor ID
- H2013:118
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 6 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are:
- 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.
- 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.
Detailed description
See above
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Counseling | Active comparator | Behavioral: Motivational CounselingThe 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. |
| Tooth Whitening Incentive | Experimental | Behavioral: Tooth Whitening, Behavioral: Motivational CounselingThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current smoker
- dental clinic patient
- interested in quitting smoking
Key exclusion criteria (2 listed)
- minors
- those unable to provide own consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth WhiteningAlso: Extrinsic vital bleaching1. 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 | Behavioural | Tooth Whitening Incentive |
| Motivational CounselingAlso: Motivational InterviewingNormally 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. | Behavioural | Motivational Counseling, Tooth Whitening Incentive |
Primary outcome
Smoking Cessation
Time frame: 1-year
1-year abstinence from tobacco use, biochemically verified by carbon monoxide breath test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas J Brothwell, DMD MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth Whitening and Motivational Counseling in people with Smoking and Smoking Cessation, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doug J Brothwell, DMD MSc (204-977-5654, Doug.Brothwell@ad.umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.