SmokingNCT00670514
Smoking Cessation in a Dentistry Setting
A study testing Nix Individual and Fimpa dig fri in people with Smoking, run by Uppsala University at 1 site in Sweden.
Trial summary
Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting. Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Nix Individual and Fimpa dig fri
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2003to not given
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult daily smokers in the county of Västmanland
Who cannot join
- Reading difficulties
- Not fluent in the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparing Study of the Smoking Cessation Program NIX Individual and the Self-Help Program Fimpa Dig Fri
Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting.
Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI).
Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).
- Conditions
- Smoking
- Being tested
- Nix Individual, Fimpa dig fri
- Keywords
- RCT, tobacco, treatment intensity, dentistry, follow-up, Smoking cessation, Cost effectiveness
- 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.
Nix IndividualBehavioural
Eight 40-minutes sessions at the local dental clinic during 4 months. Written material and counseling by a dental hygienist with special training in smoking cessation, according to a fixed program. A traditional smoking cessation program with a mixture of behavior therapy, coaching and pharmacological advises. Two questionnaires.
Fimpa dig friBehavioural
One 30-minute counseling session at the local dental clinic, focusing on explaining the content of a traditional self-help program ("Fimpa dig fri"). The leaflet contains an 8-week program with instructions and tasks to perform. Two questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 1 Nix Individual | Active comparator | High Treatment Intensity Receives: Behavioral: Nix Individual |
| 2 Fimpa dig fri | Placebo comparator | Low Treatment Intensity Receives: Behavioral: Fimpa dig fri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence
Secondary outcomes (1)
Continuous abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Västmanland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670514
- Sponsor's protocol ID
- Smoking cessation project
- Status last verified
- Apr 2008
- First submitted
- 16 Apr 2008
- Last updated
- 1 May 2008
- Results posted
- No
- Data monitoring committee
- 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 33605440Nohlert E, Ohrvik J, Tegelberg A, Tillgren P, Helgason AR. Long-term follow-up of a high- and a low-intensity smoking cessation intervention in a dental setting--a randomized trial. BMC Public Health. 2013 Jun 19;13:592. doi: 10.1186/1471-2458-13-592.
PubMed 23777201Nohlert E, Tegelberg A, Tillgren P, Johansson P, Rosenblad A, Helgason AR. Comparison of a high and a low intensity smoking cessation intervention in a dentistry setting in Sweden: a randomized trial. BMC Public Health. 2009 Apr 30;9:121. doi: 10.1186/1471-2458-9-121.
PubMed 19405969
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparing Study of the Smoking Cessation Program NIX Individual and the Self-Help Program Fimpa Dig Fri
- ClinicalTrials.gov ID
- NCT00670514
- Acronym / sponsor ID
- Smoking cessation project
- Conditions
- Smoking
- Keywords
- RCT, tobacco, treatment intensity, dentistry, follow-up, Smoking cessation, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Study start
- Apr 2003
- First posted
- 1 May 2008 (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.
Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting.
Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI).
Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Nix Individual | Active comparator | Behavioral: Nix IndividualHigh Treatment Intensity |
| 2 Fimpa dig fri | Placebo comparator | Behavioral: Fimpa dig friLow Treatment Intensity |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult daily smokers in the county of Västmanland
Key exclusion criteria (2 listed)
- Reading difficulties
- Not fluent in the Swedish language
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 |
|---|---|---|
| Nix IndividualEight 40-minutes sessions at the local dental clinic during 4 months. Written material and counseling by a dental hygienist with special training in smoking cessation, according to a fixed program. A traditional smoking cessation program with a mixture of behavior therapy, coaching and pharmacological advises. Two questionnaires. | Behavioural | 1 Nix Individual |
| Fimpa dig friOne 30-minute counseling session at the local dental clinic, focusing on explaining the content of a traditional self-help program ("Fimpa dig fri"). The leaflet contains an 8-week program with instructions and tasks to perform. Two questionnaires. | Behavioural | 2 Fimpa dig fri |
Primary outcome
Point prevalence abstinence
1 secondary outcome
Continuous abstinence
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 1 May 2008.
- 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.
- Derived from this study: PubMed 23777201Nohlert E, Ohrvik J, Tegelberg A, Tillgren P, Helgason AR. Long-term follow-up of a high- and a low-intensity smoking cessation intervention in a dental setting--a randomized trial. BMC Public Health. 2013 Jun 19;13:592. doi: 10.1186/1471-2458-13-592.
- Derived from this study: PubMed 19405969Nohlert E, Tegelberg A, Tillgren P, Johansson P, Rosenblad A, Helgason AR. Comparison of a high and a low intensity smoking cessation intervention in a dentistry setting in Sweden: a randomized trial. BMC Public Health. 2009 Apr 30;9:121. doi: 10.1186/1471-2458-9-121.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nix Individual and Fimpa dig fri in people with Smoking, run by Uppsala University at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 1 May 2008. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
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 abstinence. 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 NCT00670514, which also lists 3 linked publications.
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 1 May 2008.