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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20565724
Publication citations
-
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.