Periodontal Intervention for Smoking cessation (PARIS): Combining individual-based smoking cessation counseling, pharmacotherapy, and dental hygiene intervention

ISRCTN	ISRCTN67470159
DOI	https://doi.org/10.1186/ISRCTN67470159
Protocol serial number	N/A
Sponsor	Swiss Tobacco Prevention Fund (Switzerland)
Funders	Swiss Tobacco Prevention Fund (Switzerland), Federal Office for Public Health (Office Fédéral de la Santé Publique [OFSP]) (Switzerland) - Smoking Prevention Fund (Fonds de prévention du tabagisme)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jacques Cornuz
Scientific

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

Primary study design	Interventional
Study design	A non-controlled feasibility pilot study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	A pilot study combining individual-based smoking cessation counseling, pharmacotherapy, and dental hygiene intervention
Study acronym	PARIS
Study objectives	The present study assessed the feasibility and acceptability of integrating dentists in a medical smoking cessation intervention.
Ethics approval(s)	The Lausanne University ethics comittee approved on the 2nd of October 2007 (ref: 230/07)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Feasibility and acceptability of the dentist intervention, assessed by a hetero-administered questionnaire for the patient at 8 weeks.
Key secondary outcome measure(s)	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
Completion date	01/01/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key 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)
Key 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)
Date of first enrolment	01/10/2007
Date of final enrolment	01/01/2009

Dept Ambulatory Care and Community Medicine

Lausanne
1011
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/06/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes