SmokingPhase 3NCT00273156
A Brief Dental Office Intervention With Tobacco Quitline
A Phase 3 study testing Telephone quitline in people with Smoking and Nicotine Dependence, run by Mayo Clinic at 1 site in United States.
Trial summary
The novel and exploratory nature of this intervention relates to the concept of incorporating patient-specific oral health information obtained during a dental hygiene visit into the tobacco quitline counseling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Nicotine Dependence
- What is being tested?
- Telephone quitline
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Dec 2006
- Phase
- Phase 3
- 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
Patients were eligible to participate if they were cigarette smokers, older than the age of 18 years, and presenting to the dentist for routine dental prophylaxis.
Trial locations and contacts
1 site in 1 country.
About this study
The novel and exploratory nature of this intervention relates to the concept of incorporating patient-specific oral health information obtained during a dental hygiene visit into the tobacco quitline counseling. Linking the patient-specific oral health information obtained during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic loop for oral health professionals and make them a focal point for the tobacco use intervention without increasing clinical burden.
Read the detailed description
The overarching hypothesis of this line of research is: A brief office intervention with proactive tobacco quitline counseling incorporating patient-specific oral health information obtained during a dental hygiene visit (intervention) will increase prolonged abstinence rates from cigarette smoking compared to a brief office intervention alone (control) at 3 and 6 months.To test our overarching hypothesis in a Phase III clinical trial, we are first seeking R21 funding through the NIDCR Clinical Pilot Data Grant (PAR-03-043) mechanism. This R21 funding will be used to refine the design of dental clinic staff training, study implementation, and data collection procedures, to optimize the design of the definitive trial, and to test and document recruitment and data collection mechanisms.
The specific aims of this R21 proposal are:
- To design and refine preconceived models of training format, study implementation, and intervention through focus groups with dentists and dental hygienists.
- To define and refine study implementation, the referral process, recruitment, and data collection strategies and protocols through the sequential engagement of dental practices in active patient enrollment in a nonrandomized feasibility testing process.
- To develop a working Manual of Procedures (MOP) for a future Phase III clinical trial.
The feasibility study will be conducted through private practice dental clinics surrounding the Mayo Clinic in Rochester, MN. We are planning for a multicenter Phase III clinical trial involving private practice dental clinics in the communities surrounding Rochester, MN, and Indianapolis, IN, in collaboration with the Indiana University Nicotine Dependence Program.
- Conditions
- Smoking, Nicotine Dependence
- Being tested
- Telephone quitline
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone quitlineBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence tobacco abstinence at 3 and 6 months
Secondary outcomes (1)
Feasibility of recruiting patients into a dental quitline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startFeb 2005
- Primary completionJun 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Investigators
- Jon O. Ebbert, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273156
- Sponsor's protocol ID
- 1225-04
- Status last verified
- Apr 2013
- First submitted
- 6 Jan 2006
- Last updated
- 23 Apr 2013
- Results posted
- No
Publications
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
PubMed 33605440
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Dental Office Intervention With Tobacco Quitline
- ClinicalTrials.gov ID
- NCT00273156
- Acronym / sponsor ID
- 1225-04
- Conditions
- Smoking, Nicotine Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Feb 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Jan 2006 (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 novel and exploratory nature of this intervention relates to the concept of incorporating patient-specific oral health information obtained during a dental hygiene visit into the tobacco quitline counseling. Linking the patient-specific oral health information obtained during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic loop for oral health professionals and make them a focal point for the tobacco use intervention without increasing clinical burden.
Detailed description
The overarching hypothesis of this line of research is: A brief office intervention with proactive tobacco quitline counseling incorporating patient-specific oral health information obtained during a dental hygiene visit (intervention) will increase prolonged abstinence rates from cigarette smoking compared to a brief office intervention alone (control) at 3 and 6 months.To test our overarching hypothesis in a Phase III clinical trial, we are first seeking R21 funding through the NIDCR Clinical Pilot Data Grant (PAR-03-043) mechanism. This R21 funding will be used to refine the design of dental clinic staff training, study implementation, and data collection procedures, to optimize the design of the definitive trial, and to test and document recruitment and data collection mechanisms.
The specific aims of this R21 proposal are:
- To design and refine preconceived models of training format, study implementation, and intervention through focus groups with dentists and dental hygienists.
- To define and refine study implementation, the referral process, recruitment, and data collection strategies and protocols through the sequential engagement of dental practices in active patient enrollment in a nonrandomized feasibility testing process.
- To develop a working Manual of Procedures (MOP) for a future Phase III clinical trial.
The feasibility study will be conducted through private practice dental clinics surrounding the Mayo Clinic in Rochester, MN. We are planning for a multicenter Phase III clinical trial involving private practice dental clinics in the communities surrounding Rochester, MN, and Indianapolis, IN, in collaboration with the Indiana University Nicotine Dependence Program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Telephone quitline | Behavioural | – |
Primary outcome
Point prevalence tobacco abstinence at 3 and 6 months
1 secondary outcome
Feasibility of recruiting patients into a dental quitline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Derived from this study: PubMed 33605440Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
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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.
Jon O. Ebbert, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telephone quitline in people with Smoking and Nicotine Dependence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 23 Apr 2013. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence tobacco abstinence at 3 and 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00273156, which also lists 1 linked publication.
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 23 Apr 2013.