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NCT04498858: TOBAFREE-DP
To Promote Tobacco Free Life in the Dental Practice in France
trial testing Patient interview in Tobacco Cessation in 139 participants. Completed in 13 September 2021.
13 September 2021
Quick facts
| Lead sponsor | University Hospital, Bordeaux |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 139 |
| Start date | 14 April 2021 |
| Primary completion | 13 September 2021 |
| Estimated completion | 13 September 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- Patient interview
Conditions studied
- Tobacco Cessation — all drugs for Tobacco Cessation →
- Dental Practice — all drugs for Dental Practice →
Sponsor
University Hospital, Bordeaux
Who can join
18 and older, any sex, with Tobacco Cessation or Dental Practice. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04498858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04498858 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Bordeaux
- Last refreshed: 10 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04498858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing