Abstract
BackgroundTobacco 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.MethodsA 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.ResultsEighty 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).ConclusionsData 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 registrationISRCTN, ISRCTN17731903; registered 19 September 2016 http://www.isrctn.com/ISRCTN17731903.
Highlights
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
Data suggest that a definitive trial is feasible and that the intervention may improve smoking quit rates
Periodontitis, an advanced form of periodontal disease, has a multifactorial aetiology, but the principal process involves a dental plaque biofilm accumulating in the subgingival environment, causing an immune and inflammatory response that leads to destruction of the tooth supporting structures
Summary
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. Periodontal diseases are amongst the most common inflammatory conditions in humans [1]. Periodontitis, an advanced form of periodontal disease, has a multifactorial aetiology, but the principal process involves a dental plaque biofilm accumulating in the subgingival environment, causing an immune and inflammatory response that leads to destruction of the tooth supporting structures. There are multiple risk factors for periodontal diseases, but tobacco smoking is one of the most important [4]. Smoking is thought to affect the periodontal tissues via multiple pathways, including effects on the host immune and inflammatory response, impaired blood flow and microbiological changes [5]. Smoking cessation advice (SCA) is a critical component of periodontal therapy, and usual care involves a brief advice intervention, e.g. the ‘3 A’s’ technique: Ask, Advise, Act [7, 8]
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