Condition category
Mental and Behavioural Disorders
Date applied
01/02/2010
Date assigned
10/03/2010
Last edited
22/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jacques Cornuz

ORCID ID

Contact details

Dept Ambulatory Care and Community Medicine
Lausanne University Hospital
44
Bugnon Avenue
Lausanne
1011
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pilot study combining individual-based smoking cessation counseling, pharmacotherapy, and dental hygiene intervention

Acronym

PARIS

Study hypothesis

The present study assessed the feasibility and acceptability of integrating dentists in a medical smoking cessation intervention.

Ethics approval

The Lausanne University ethics comittee approved on the 2nd of October 2007 (ref: 230/07)

Study design

A non-controlled feasibility pilot study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet (In French)

Condition

Tobacco Use Prevention

Intervention

Smokers willing to quit underwent an 8-week smoking cessation intervention combining individual-based counseling and nicotine replacement therapy and/or bupropion, provided by a general internist. In addition, a dentist provided a dental exam combined with oral hygiene treatment and information about chronic effects of smoking on oral health during two visits, at week 1 and week 2.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Feasibility and acceptability of the dentist intervention, assessed by a hetero-administered questionnaire for the patient at 8 weeks.

Secondary outcome measures

1. Smoking cessation rates, assesed by hetero-administered questionnaire and carbon monoxide expiration test at 8 weeks and 6 months.
2. Changes in orodental status, assessed by an oro-dental exam by the dentist at the 2nd visit

Overall trial start date

01/10/2007

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 18 and 70
2. Currently smoking for ≥ 3 years at least 10 cig./day
3. Motivation to quit smoking of 6/10 or more on the Likert Scale (from 0 to 10)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Current pharmacological use to quit smoking
2. Presence of an unstable or life-threatening medical condition
3. Current psychiatric illness
4. At risk alcohol consumption
5. Illegal drug consumption, such as cannabis
6. Meets American Heart Association's criteria for antibiotic-prophylaxis before dental intervention (Wilson, et al., 2007)
7. Long-term bisphosphonate treatment
8. Recent oral hygiene intervention (< 6 months)

Recruitment start date

01/10/2007

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Switzerland

Trial participating centre

Dept Ambulatory Care and Community Medicine
Lausanne
1011
Switzerland

Sponsor information

Organisation

Swiss Tobacco Prevention Fund (Switzerland)

Sponsor details

Office fédéral de la santé publique
Fonds de prévention du tabagisme
Case postale
Berne
3003
Switzerland

Sponsor type

Other

Website

http://www.bag.admin.ch/tabak_praevention/index.html?lang=fr

Funders

Funder type

Government

Funder name

Swiss Tobacco Prevention Fund (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federal Office for Public Health (Office Fédéral de la Santé Publique [OFSP]) (Switzerland) - Smoking Prevention Fund (Fonds de prévention du tabagisme)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20565724

Publication citations

  1. Results

    Gonseth S, Abarca M, Madrid C, Cornuz J, A pilot study combining individual-based smoking cessation counseling, pharmacotherapy, and dental hygiene intervention., BMC Public Health, 2010, 10, 348, doi: 10.1186/1471-2458-10-348.

Additional files

Editorial Notes