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To Promote Tobacco Free Life in the Dental Practice in France (TOBAFREE-DP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04498858
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : September 10, 2021
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

In France, 34% of the adult population is smoking every day. The links between smoking and the development of several chronic disorders is well established and smoking is directly implicated in most of the oral diseases such as cancers of the oral cavity. Thus, dentists have access to an area of the body that is actively affected and this gives them a central role in dispensing advice and support regarding smoking cessation.

Dentists often cite issues such as lack of time or education as a reason for why they do not offer support for smoking cessation. A brief intervention can increase smoking cessation by 30 to 100% (ie 1-3% in absolute value). The "5A" approach integrates and extends the brief intervention. It consists in Asking about smoking status, Advising smokers of the benefit of stopping, Assessing motivation to quit, Assisting smokers in their quit attempt, Arranging follow-up with stop-smoking services. For practitioners who do not have enough time, a "3A" approach might be acceptable (Ask, Advice and Act) by providing details of local stop smoking services and/or prescribing nicotine replacement therapy (NRT). This very brief advice can be delivered in less than one minute.

To investigators knowledge, the role of dentists in the French national tobacco-free program is not yet documented in France while since 2016, dentists can prescribe NRT with some products taken in charge by the French health insurance.

An intervention taking part in the continuing professional development will be developed so the dentists fell legitimate, motivated and competent to talk with their patients about their tobacco consumption and to assist them in their smoking cessation process. This intervention based on the 5/3A approach and prescription of NRT will include a specific training and provision of management kit, with communication tools and network for appropriate references.

Investigators hypothesize that 5/3A approach is feasible with adequate intervention in dental practices in France (dentists apply the approach to 90% of their patients) and that the format, the conditions, the barriers and the lever actions of its implementation are known.

Condition or disease Intervention/treatment
Tobacco Cessation Dental Practice Other: Patient interview

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Study Type : Observational
Estimated Enrollment : 480 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Promote Tobacco Free Life in the Dental Practice in France: Feasibility Study
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort Intervention/treatment
Patient Other: Patient interview

Patient will be interviewed :

  • tobacco consumption
  • reported question asked by the dentist about his/her tobacco consumption
  • presence and nature of reported advices given by the dentist
  • presence and nature of actions proposed by dentists for patients reporting tobacco consumption, including prescription of NRT
  • presence and nature of the actions carried out or envisaged by these patients, including - smoking cessation
  • contact with the general practioner
  • Fagerstrom score (2 questions)
  • demographic variables, age, sex, level of education
  • satisfaction

Primary Outcome Measures :
  1. 5/3A approach [ Time Frame: 1 month after inclusion (day0) ]
    Acceptability for performing the 5/3A approach in the dental practice

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients of trained dentists to 3/5A strategy

Inclusion Criteria:

  • 18 years or older
  • smoker
  • Will to participate to study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04498858

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Contact: Elise ARRIVE, Dr 06 62 83 66 58

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CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Elise ARRIVE, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux Identifier: NCT04498858    
Other Study ID Numbers: CHUBX 2018/70
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Tobacco cessation
dental practice
nicotine replacement therapy