Title: Electronic cigarettes as a smoking cessation and harm reduction tool in patients with periodontitis: A mixed methods feasibility study.
Funder: Department of Health and Social Care

Abstract: Background Periodontal diseases are highly prevalent and have a significant impact on the quality of life of large proportions of the population. For example 10% of the UK adult population suffer from severe forms of periodontal diseases. The pathogenesis is multifactorial and several key risk factors have been identified. Among these, tobacco smoking is the most important known risk factor. Smokers have consistently demonstrated more severe disease and increased tooth loss compared to non-smokers. Research has shown that tobacco smokers have inferior outcomes following periodontal therapies compared to non-smokers or those who successfully quit, which is of particular relevance to dentists. Indeed, smokers who quit are 30% more likely to see clinically significant improvements than individuals who continue to smoke. Smoking cessation rates however remain low with only 15% of patients successfully abstaining from tobacco for 1 year. The development of electronic cigarettes(e-cigarettes), devices that deliver a vapour containing nicotine, flavourings and diluents, have added a new dimension to tobacco research. Although large numbers of our patients are using e-cigarettes relatively little is known about their smoking cessation effectiveness and the potential effect on the periodontal tissues in terms of treatment outcomes. Our hypothesis is that e-cigarette vapour is significantly less damaging than tobacco smoke and that e-cigarettes are attractive to smoking patients with periodontitis (as a smoking cessation/reduction aid), leading to improved periodontal treatment outcomes. Design This study is a mixed methods feasibility study, comprising a randomised controlled trial (RCT) and embedded qualitative process evaluation. Eighty patients will undergo non-surgical periodontal therapies. The control arm will be offered standard smoking cessation advice/referral and the intervention arm will be offered standard smoking cessation advice/referral and in addition will be provided with an e-cigarette. The follow up period will be 6 months following the completion of the periodontal therapy. Objectives Future definitive trial objectives: To determine the effect on periodontal treatment outcomes and the smoking cessation/reduction effectiveness of e-cigarette provision in smokers undergoing periodontal therapy. Mixed methods feasibility study: The objectives are: to show that recruitment to such a trial is possible; to assess rates of treatment compliance, group cross-over and retention for data collection; to assess acceptability of the trial processes and of the trial intervention from a patient perspective; to assess which participants use e-cigarettes and how they use them; to test potential outcome measures for the future definitive trial; to test data collection methods; to observe changes in smoking behaviour; to describe differences for smoking abstinence, smoking reduction and periodontal health between and within groups; exploratory analysis of secondary outcome measures (microbiological and immunological) and complete a qualitative process evaluation.Expected outcomes and anticipated benefit The primary outcomes from this feasibility study will be estimates of unknown variables (such as recruitment, retention and compliance rates) and the distributions of potential primary outcomes for the future definitive trial. Additional outcomes will involve exploring changes in the microbiota and the inflammatory process as well as a qualitative process evaluation. These will help inform our understanding of the potential biological implications of e-cigarettes as well as answer fundamental questions regarding their potential appeal to patients and how best to utilise this technology as a health care intervention. Definitive outputs will result from this work.A future definitive trial would aim to establish the effects on the periodontal treatment outcomes and smoking cessation/reduction effectiveness of e-cigarettes, both areas where there is currently no guidance. This has huge potential to inform and benefit a large number of patients with over 50% of all cases of periodontitis being attributed to cigarette smoking, equating to approximately 2.2million people in the UK.

Lay abstract: Background Periodontitis (gum disease) is one of the most common diseases in humans. The disease involves bacteria in the form of dental plaque building up on teeth and causing inflammation (irritation) of the gum tissues. Over time, the structures that support the teeth are destroyed and the teeth become loose. Approximately half of the UK adult population suffer from moderate periodontal disease. 1 in 10 adults suffer from severe disease. Several risk factors have been identified for periodontitis including poor oral hygiene, diabetes and cigarette smoking. Cigarette smoking is the most important known risk factor. It has effects on the bacteria present as well as how the body reacts. Smokers are more likely to develop periodontitis and five times more likely to lose a tooth. Smokers who receive periodontal treatments from their dentist will also have worse outcomes if they continue to smoke. In the UK around 1 in 5 adults currently smoke. Around half of those with periodontitis are smokers. Dentists will encourage patients to stop smoking, especially if they suffer from gum diseases. Quitting smoking can, however, be very difficult. If smokers try to quit without any support then only a small number (around 4%) will succeed. There are a range of options for smokers motivated to quit including: willpower alone, brief advice from a health professional or more intensive support through NHS stop smoking services (involving behavioural support and access to licensed stop smoking medications such as Nicotine Replacement Therapy). If smokers attempt to quit with support their chance of staying off cigarettes improves to 15%. The recent development of electronic cigarettes (e-cigarettes) offers another option to smokers. E-cigarettes are electrical devices that deliver a vapour containing nicotine and flavourings. E-cigarettes may be able to help smokers reduce the number of normal cigarettes they smoke and may help some totally quit. With e-cigarettes being so new there are only a few research studies. So far they indicate e-cigarettes may be a very powerful tool for smokers trying to quit or cut down. There is no research looking specifically at the effects of e-cigarettes in patients with periodontitis. Aims This is a mixed methods feasibility study being conducted before a larger definitive trial. The future definitive trial will aim to answer two questions: Is e-cigarette use beneficial for periodontal treatment outcomes? Are e-cigarettes useful in helping smoking patients (with periodontitis) to reduce or totally quit smoking? This feasibility study is testing several aspects of the trial design and will help design a definitive trial that works optimally. Additionally we will be developing knowledge around the possible biological processes involved and about patients opinions. Design and methods There will be 80 participants recruited to this feasibility study who will: be current smokers of over 10 cigarettes/day have periodontitis. The study will have a randomised controlled trial design. Participants will be allocated at random to one of two groups: those who receive standard smoking cessation advice/referral' (control group). those who receive standard smoking cessation advice/referral' AND are provided with an e-cigarette (intervention group). All participants will receive routine periodontal treatments. These involve scaling of the teeth over 2 visits, usually on consecutive days. Participants will be followed up for 6 months. The treatment aspects of the study will be provided by Dr Richard Holliday. The measurements of periodontal health will be collected by a research hygienist who is not aware of the smoking status of the participants. Patient and Public Involvement During the development of this project I have worked closely with three different patient panels. They have provided excellent feedback on participant recruitment, opinions on e-cigarettes and how to provide e-cigarettes within this study. As the study progresses it will be very important to get the opinions of patients on study procedures, study interventions and dissemination of findings. I will establish a group of patients who will meet to help me design the study and make it as patient friendly as possible. They will be able to help me write appropriate information for participants and they will meet regularly during the project. Dissemination The results of this feasibility study will be of key importance in the design of the definitive trial. They will also be of interest to other researchers and I will present the results at conferences. I will also publish papers in scientific journals. Once I complete the main trial these results will also be of interest to a wider range of people including: policy makers, regulators, public health officials and the general public.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: ORAL AND GASTROINTESTINAL