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ISRCTN
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ISRCTN67470159
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ClinicalTrials.gov identifier
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Public title
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Periodontal Intervention for Smoking cessation (PARIS): Combining individual-based smoking cessation counseling, pharmacotherapy, and dental hygiene intervention
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Scientific title
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A pilot study combining individual-based smoking cessation counseling, pharmacotherapy, and dental hygiene intervention
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Acronym
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PARIS
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Serial number at source
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N/A
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Study hypothesis
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The present study assessed the feasibility and acceptability of integrating dentists in a medical smoking cessation intervention.
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Lay summary
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Ethics approval
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The Lausanne University ethics comittee approved on the 2nd of October 2007 (ref: 230/07)
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Study design
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A non-controlled feasibility pilot study
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Tobacco Use Prevention
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/10/2007
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Anticipated end date
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01/01/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet (In French)
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Target number of participants
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40
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Interventions
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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.
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Primary outcome measure(s)
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Feasibility and acceptability of the dentist intervention, assessed by a hetero-administered questionnaire for the patient at 8 weeks.
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Swiss Tobacco Prevention Fund (Switzerland)
2. Federal Office for Public Health (Office Fédéral de la Santé Publique [OFSP]) (Switzerland) - Smoking Prevention Fund (Fonds de prévention du tabagisme)
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Trial website
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Publications
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Contact name
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Prof
Jacques
Cornuz
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Address
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Dept Ambulatory Care and Community Medicine
Lausanne University Hospital
44, Bugnon Avenue
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City/town
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Lausanne
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Zip/Postcode
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1011
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Country
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Switzerland
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Sponsor
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Swiss Tobacco Prevention Fund (Switzerland)
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Address
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Office fédéral de la santé publique
Fonds de prévention du tabagisme
Case postale
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City/town
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Berne
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Zip/Postcode
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3003
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Country
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Switzerland
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Sponsor website:
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http://www.bag.admin.ch/tabak_praevention/index.html?lang=fr
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Date applied
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01/02/2010
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Last edited
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10/03/2010
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Date ISRCTN assigned
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10/03/2010
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