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Pilot Feasibility Stud. 2019 Jun 4;5:74. doi: 10.1186/s40814-019-0451-4. eCollection 2019.

A feasibility study with embedded pilot randomised controlled trial and process evaluation of electronic cigarettes for smoking cessation in patients with periodontitis.

Author information

1
1Centre for Oral Health Research, School of Dental Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, NE2 4BW UK.
2
2National University Centre for Oral Health, National University of Singapore, Singapore, Singapore.
3
3Institute of Health & Society, Newcastle University, Newcastle upon Tyne, NE2 4AX UK.
4
4Centre for Clinical Research, The University of Queensland, Building 71/918, Royal Brisbane and Women's Hospital Campus, Herston, Queensland 4029 Australia.
5
5Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, EH8 9AG UK.

Abstract

Background:

Tobacco smoking is a major risk factor for several oral diseases, including periodontitis, and electronic cigarettes (e-cigarettes) are increasingly being used for smoking cessation. This study aimed to assess the viability of delivering and evaluating an e-cigarette intervention for smoking cessation within the dental setting, prior to a definitive study.

Methods:

A feasibility study, comprising a pilot randomised controlled trial and qualitative process evaluation, was conducted over 22 months in the Newcastle upon Tyne Hospitals NHS Dental Clinical Research Facility, UK. The pilot trial comprised a two-armed, parallel group, individually randomised, controlled trial, with 1:1 allocation. Participant eligibility criteria included being a tobacco smoker, having periodontitis and not currently using an e-cigarette. All participants received standard non-surgical periodontal therapies and brief smoking cessation advice. The intervention group additionally received an e-cigarette starter kit with brief training. Proposed outcomes for a future definitive trial, in terms of smoking behaviour and periodontal/oral health, were collected over 6 months to assess data yield and quality and estimates of parameters. Analyses were descriptive, with 95% confidence intervals presented, where appropriate.

Results:

Eighty participants were successfully recruited from a range of dental settings. Participant retention was 73% (n = 58; 95% CI 62-81%) at 6 months. The e-cigarette intervention was well received, with usage rates of 90% (n = 36; 95% CI 77-96%) at quit date. Twenty percent (n = 8; 95% CI 11-35%) of participants in the control group used an e-cigarette at some point during the study (against advice). The majority of the outcome measures were successfully collected, apart from a weekly smoking questionnaire (only 30% of participants achieved ≥ 80% completion). Reductions in expired air carbon monoxide over 6 months of 6 ppm (95% CI 1-10 ppm) and 12 ppm (95% CI 8-16 ppm) were observed in the control and intervention groups, respectively. Rates of abstinence (carbon monoxide-verified continuous abstinence for 6 months) for the two groups were 5% (n = 2; 95% CI 1-17%; control group) and 15% (n = 6; 95% CI 7-29%; intervention group).

Conclusions:

Data suggest that a definitive trial is feasible and that the intervention may improve smoking quit rates. Insights were gained into how best to conduct the definitive trial and estimates of parameters to inform design were obtained.

Trial registration:

ISRCTN, ISRCTN17731903; registered 19 September 2016 http://www.isrctn.com/ISRCTN17731903.

KEYWORDS:

Cessation; Dental; Electronic cigarettes; Oral health; Periodontitis; Smoking; Tobacco

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

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