Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dental professionals in Sweden are in a unique position to give advice on quitting smoking, since a high proportion of the adult population (about 84%) visit a dental clinic at least every other year, most of the visits having a preventive scope. However, there are no Swedish studies on the effectiveness of brief advice for quitting smoking delivered in dental clinics, and its feasibility on a systematic basis is not known. This study aims to fill this gap by evaluating the feasibility and effectiveness of a brief structured counseling to help tobacco users to quit the habit .

Who can participate?
Patients in dental clinics of both sexes, age 18-75 years, who have smoked tobacco daily for at least 1 year and are not currently treated for tobacco dependence.

What does the study involve?
About 30 dental clinics (both publicly and privately run) in two regions of Central Sweden will be randomly allocated to one of two groups: either the intervention group or the control group. At the intervention group clinics trained dental care professionals will deliver a brief and structured motivational counseling to quit smoking. At the control group clinics patients will receive usual care.

What are the possible benefits and risks of participating?
There are no risks connected to the intervention, which is based on behavioral counseling. On the other hand, the health advantages of quitting smoking are widely known.

Where is the study run from?
Department of Public Health Sciences at Karolinska Institutet (Sweden).

When is the study starting and how long is it expected to run for?
The study is expected to run from October 2012 to September 2013.

Who is funding the study?
Swedish Government - National Board of Health and Welfare.

Who is the main contact?
Associate Professor Maria Rosaria Galanti

Trial website

Contact information



Primary contact

Dr Maria Rosaria Galanti


Contact details

Department of Public Health Sciences
Karolinska Institutet
+46 812 337 165

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A cluster randomized controlled trial for the evaluation of brief motivational counseling for tobacco cessation among patients attending dental clinics in Central Sweden


FRITT (Free from Tobacco in Dental Care)

Study hypothesis

The point prevalence of abstinence from tobacco after 6 months will be at least 100% higher among patients undergoing the brief intervention under evaluation compared to controls in usual care.

Ethics approval

Ethical Review Board of Stockholm Region, 15/03/2102, ref: 2012/237-31/5

Study design

Single-center intervention study with randomized 1:1 allocation of 30 dental clinics and 460 patients thereof to intervention (brief motivational advice) or control (usual care).

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Smoking and smokeless tobacco cessation


The intervention consists of a manualized brief motivational counseling developed by a chartered psychologist on behalf of the Swedish National Institute for Public Health, including referral to second-level tobacco cessation services. The brief counseling is based on a modified version of the 5 A (ask, advise, assess motivation, assist, arrange).
The counseling will be delivered by either a dentist or a dental hygienist to consenting consecutive patients in the intervention group during an ordinary visit. The approximate duration of the counseling will be about 5 minutes and will end with the offer of referral to a second-level cessation service, such as specialized cessation counseling at the health care district or telephone Quit-Line.

The control condition consists of 'usual care', i.e. the praxis followed in the corresponding clinic to advise patients to quit tobacco, if any. No effort will be made to standardize this condition. An investigation carried out among the clinics prior to inclusion in the trial showed a low proportion of clinics with guidelines and training of personnel on tobacco cessation.

Patients in both groups will answer a structured questionnaire at time 0 (recruitment) and 6 months after (follow-up), encompassing information on own tobacco use as well as on selected psycho-social predictors of tobacco use.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Point prevalence of total abstinence from tobacco (no use of tobacco in the 7 days preceding the follow-up survey) 6 months after recruitment.

Secondary outcome measures

1. Prevalence of sustained abstinence from tobacco during the 3 months preceding the survey
2. Proportion of patients reporting cutting tobacco consumption by at least 50% at follow-up compared to baseline
3. Proportion of patients reporting quit attempts (at least 24 hours abstinence from tobacco) during the past 6 months
4. Number of quit attempts

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Attend dental care during the study period
2. Age between 18 and 75
3. Daily smokers and/or smokeless tobacco users (used tobacco in all of the preceding 30 days)
4. Continued tobacco use for at least 1 year
5. Provide informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Unable to speak and read basic conversational Swedish
2. Serious psychiatric co-morbidity, alcohol problems, or regular use of addictive substances other than tobacco
3. Currently in treatment (behavioral or pharmacologic) for tobacco cessation
4. Seeking treatment for acute dental illness

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Public Health Sciences

Sponsor information


National Board of Health and Welfare (Sweden)

Sponsor details


Sponsor type




Funder type


Funder name

National Board of Health and Welfare (Socialstyrelsen) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes