Smoking Cessation in a Dentistry Setting

April 30, 2008 updated by: Uppsala University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Västerås, Sweden, 721 89
        • Centre for clinical research, Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult daily smokers in the county of Västmanland

Exclusion Criteria:

  • Reading difficulties
  • Not fluent in the Swedish language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 Nix Individual
High Treatment Intensity
Behavioral: Nix Individual
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.
Placebo Comparator: 2 Fimpa dig fri
Low Treatment Intensity
Behavioral: Fimpa dig fri
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Point prevalence abstinence

Secondary Outcome Measures

Outcome Measure
Continuous abstinence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Västmanland County Council, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

May 1, 2008

Last Update Submitted That Met QC Criteria

April 30, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Smoking cessation project

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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