Title: ENHANCE-D - Enhancing Dental Health Advice
Funder: Department of Health and Social Care

Abstract: Smoking is a major cause of illness and death in the UK. It affects both general and oral health. Around three-quarters of the 7200 new cases of mouth and throat cancer diagnosed in the UK each year are due to smoking._x000D_ _x000D_ Smoking is also a big risk factor for gum disease (‘periodontitis’). This affects 1 in 10 UK adults and often leads to tooth loss. Quitting smoking is an effective way to improve oral health. Helping patients to quit is one of the most important aspects of dental care. For those with gum disease, their treatments will work better if they quit._x000D_ _x000D_ There are many ways to support smokers to quit. These include behavioural support, medications such as nicotine replacement therapy (NRT), or e-cigarettes._x000D_ _x000D_ Dental teams currently offer ‘very brief advice’ (VBA) to patients who smoke. This involves a short discussion and sometimes a referral elsewhere, such as to a doctor or Stop Smoking Service, for further support. _x000D_ _x000D_ Of all healthcare providers, dental teams are probably best placed to offer extra quitting support. They see a large number of patients regularly. They notice changes in the mouth related to smoking, such as loose teeth and staining. These changes can be used as powerful prompts for a quit attempt._x000D_ _x000D_ We have recently carried out a small scale study on how dental teams can help patients quit smoking. A larger study is now urgently needed to tell us:_x000D_ 1) Does providing extra quitting support in the dental clinic improve smoking quit rates and gum health?_x000D_ 2) Is providing this support good value for money?_x000D_ _x000D_ We will invite adult smokers from NHS dental clinics to take part. 1460 patients will be put into one of three treatment groups. The treatment they get will be decided at random using a computerised system. 20% (292) will get VBA. 40% (584) will get NRT. 40% (584) will get e-cigarettes. _x000D_ _x000D_ We will ask patients if they are still smoking during their check-up visits at 6 and 12 months. What they tell us will be checked with special breath tests. Patients who have gum disease will have detailed examinations of their oral health. _x000D_ _x000D_ We will collect samples of the bacteria from under the gum. We will also collect samples of cells from the cheek. These samples will allow us to test our understanding of the basic biology involved. _x000D_ _x000D_ We will have detailed review sessions with some patients and dental teams. These will help us to understand how extra support for helping people quit smoking would work in routine practice. _x000D_ _x000D_ The study is expected to take almost 4 years to complete. In the early months, we will test our study processes to iron out any issues. Each patient will be in the study for 1 year. _x000D_ _x000D_ Dental patients, dental professionals, and researchers helped design this study. We have written about what we did in a national blog post (bit.ly/2SXFMb6). At the end of the study, we will publicise the findings widely. We will write papers for the journals read by dental professionals. We will also run a national publicity roadshow, webinars, and social media campaigns._x000D_ _x000D_ The findings of this study will have a big impact on the experience that smokers have when visiting the dentist. Clinical guidelines and national policies will be updated to tell dental teams about the best way to help smokers quit.

Lay abstract: Smoking remains one of the principal risk factors for oral diseases, specifically periodontitis and oral cancer/pre-cancer. Dental professionals currently offer very brief advice (VBA) interventions; the ENHANCE-D Trial evaluates if enhanced interventions are clinically- and cost-effective in terms of smoking abstinence and oral health improvement. Mechanisms of oral health change will be evaluated by testing pre-defined hypotheses (pending further funding)._x000D_ _x000D_ DESIGN: a pragmatic, multi-centre, phase III definitive, open label, 3 arm, parallel group, individually randomised controlled, superiority trial, comparing the clinical- and cost-effectiveness, and safety of enhanced smoking cessation interventions to usual care, and each other (with an internal pilot). A subgroup of participants with periodontitis will be examined by a blinded dental hygienist at baseline and 6 months._x000D_ _x000D_ SETTING: 56 NHS primary dental care settings across 7 regions of the UK_x000D_ _x000D_ POPULATION: Adult regular smokers attending a NHS dental setting_x000D_ _x000D_ INCLUSION: Adults aged >=18 years; current regular smoker; had a Basic Periodontal Examination in the last 3 months. Periodontitis subgroup: >16 natural teeth; periodontitis >= stage II, grade A/B/C, currently unstable._x000D_ _x000D_ EXCLUSION: Used Nicotine Replacement Therapy (NRT) or an e-cigarettes (EC) in the week prior to enrolment; pregnant or breastfeeding; enrolled in other interventional research; contra-indications for nicotine use or smoking cessation; unable to provide informed consent._x000D_ _x000D_ PRIMARY OUTCOME: Continuous biochemically verified smoking abstinence at 6 months_x000D_ _x000D_ KEY POWERED SECONDARY OUTCOME: Percentage of periodontal sites with pocket probing depths >=5 mm at 6 months (periodontitis subgroup, blinded endpoint)._x000D_ _x000D_ OTHER SECONDARY OUTCOMES:_x000D_ Clinical (all): smoking abstinence at 12 months; prevalence of oral potentially malignant disorders._x000D_ Clinical (periodontitis subgroup): Full periodontal indices, clinical oral dryness score._x000D_ Patient-centred: Oral health-related quality of life, nicotine dependence, urges to smoke and withdrawal symptoms._x000D_ Mechanistic: Genomic and transcriptomic analysis of the microbiome and mucosa._x000D_ Economic: Cost-effectiveness and cost-benefit analysis._x000D_ Qualitative: Explore experience, confirm acceptability and identify strategies for implementation. _x000D_ _x000D_ INTERVENTIONS: All participants will be provided with a usual care package of oral health advice. The smoking cessation component will vary by randomisation group (1:2:2 ratio)._x000D_ 1) VBA: usual care (control)._x000D_ 2) NRT: standard 12-week course of combination NRT with single-visit behavioural support._x000D_ 3) EC starter kit: including 2 e-liquid bottles and single-visit behavioural support._x000D_ _x000D_ SAMPLE SIZE: Bonferroni-based gate keeping method. 1) The superiority of either EC or NRT vs. VBA for the primary outcome and the key (powered) secondary outcome will be tested. 2) Superiority of EC vs. NRT will be tested only if >= 1 of the previous hypothesis tests were rejected, per outcome. Overall, 1460 participants will be required, with 455 in the periodontitis subgroup._x000D_ _x000D_ TIMELINES: The project will run for 45 months, with participant follow-up at 6 and 12 months. Internal pilot with stop/go assessment at 8 months._x000D_ _x000D_ IMPACT AND DISSEMINATION: Evidence in this area is likely to change policy, guidance and clinical practice. Our team is well positioned to influence guidelines and disseminate findings to the dental, tobacco control and patient/public communities.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;RESPIRATORY;STROKE