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

Article


Holliday, Richard, Preshaw, Philip M., Ryan, Vicky, Sniehotta, Falko F., McDonald, Suzanne, Bauld, Linda and McColl, Elaine. 2019. "A feasibility study with embedded pilot randomised controlled trial and process evaluation of electronic cigarettes for smoking cessation in patients with periodontitis." Pilot and Feasibility Studies. 5, pp. 1-14. https://doi.org/10.1186/s40814-019-0451-4
Article Title

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

ERA Journal ID213957
Article CategoryArticle
AuthorsHolliday, Richard (Author), Preshaw, Philip M. (Author), Ryan, Vicky (Author), Sniehotta, Falko F. (Author), McDonald, Suzanne (Author), Bauld, Linda (Author) and McColl, Elaine (Author)
Journal TitlePilot and Feasibility Studies
Journal Citation5, pp. 1-14
Article Number74
Number of Pages14
Year2019
PublisherBioMed Central Ltd.
Place of PublicationUnited Kingdom
ISSN2055-5784
Digital Object Identifier (DOI)https://doi.org/10.1186/s40814-019-0451-4
Web Address (URL)https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0451-4
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.

KeywordsElectronic cigarettes; Smoking; Tobacco; Periodontitis; Dental; Oral health; Cessation
ANZSRC Field of Research 2020320310. Periodontics
Byline AffiliationsNewcastle University, United Kingdom
University of Queensland
University of Edinburgh, United Kingdom
Open access urlhttps://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0451-4
Institution of OriginUniversity of Southern Queensland
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