Dentists will test whether giving smokers nicotine patches or e-cigarette starter kits alongside routine check-ups helps them quit more effectively than standard brief advice alone. Smoking is a major cause of gum disease and oral cancer, yet dental professionals currently offer only very brief advice to quit. The ENHANCE-D trial, running across 56 NHS dental practices in seven UK regions, will randomise 1,215 adult smokers into three groups: usual care, a 12-week course of nicotine replacement therapy (NRT) with behavioural support, or an e-cigarette starter kit with behavioural support. A subgroup of patients with periodontitis will have their gum health assessed by a blinded dental hygienist at six months. The primary outcome is biochemically verified smoking abstinence at six months; secondary outcomes include periodontal healing, oral cancer precursor lesions, quality of life, and cost-effectiveness. If either enhanced intervention proves superior, the findings could shift NHS dental guidance and clinical practice, embedding smoking cessation support into routine dental care. This would directly reduce the burden of smoking-related oral disease and potentially save lives, while offering a scalable model for primary care settings.
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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). 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. SETTING: 56 NHS primary dental care settings across 7 regions of the UK POPULATION: Adult regular smokers attending a NHS dental setting 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. 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. PRIMARY OUTCOME: Continuous biochemically verified smoking abstinence at 6 months KEY POWERED SECONDARY OUTCOME: Percentage of periodontal sites with pocket probing depths >=5 mm at 6 months (periodontitis subgroup, blinded endpoint). OTHER SECONDARY OUTCOMES: Clinical (all): smoking abstinence at 12 months; prevalence of oral potentially malignant disorders. Clinical (periodontitis subgroup): Full periodontal indices, clinical oral dryness score. Patient-centred: Oral health-related quality of life, nicotine dependence, urges to smoke and withdrawal symptoms. Mechanistic: Genomic and transcriptomic analysis of the microbiome and mucosa. Economic: Cost-effectiveness and cost-benefit analysis. Qualitative: Explore experience, confirm acceptability and identify strategies for implementation. 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). 1) VBA: usual care (control). 2) NRT: standard 12-week course of combination NRT with single-visit behavioural support. 3) EC starter kit: including 2 e-liquid bottles and single-visit behavioural support. 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, 1215 participants will be required, with up to 455 in the periodontitis subgroup. TIMELINES: The project will run for 58 months, with participant follow-up at 6 and 12 months. Internal pilot with stop/go assessment at 8 months. 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.
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