Smoking cessation in dental patients with or without gum disease Oral Health Smokers attending general dental practice, with or without periodontitis
Conditions
Interventions
Control arm
i. Very Brief Advice (VBA)
1. VBA is usual care for smokers in dental settings usually following the 3As: Ask, Advise, Act technique. This will signpost participants to a GP, pharmacy or s
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years old 2. Current regular smoker 3. Willing and able to provide informed consent prior to any trial procedures taking place 4. A basic Periodontal Examination completed within the last 3 months. Periodontitis subgroup: 5. Minimum of 16 natural teeth (excluding third molars) 6. For sub-group - diagnosis of periodontitis stage II (or greater), grade A/B/C and currently unstable (As diagnosed by the primary care dentist/hygienist/therapist)
Exclusion criteria
Exclusion criteria: 1. Known to be pregnant or currently breastfeeding 2. Enrolled in another interventional research trial which could affect the outcome of this trial 3. Having used an aid to quit smoking or reduce/quit alcohol in the week prior to enrolment 4. Phaeocromocytoma, uncontrolled hyperthrodism, extensive dermatitis/skin disorder 5. Known hypersensitivity to nicotine or any component of the study products 6. Taking one of the following medications: 6.1. Clozapine 6.2. Olanzapine 6.3. Theophylline 6.4. Aminophylline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemically verified smoking abstinence 6 months after randomisation using a carbon monoxide monitor | — |
Secondary
| Measure | Time frame |
|---|---|
| To all participants: 1. Continuous biochemically verified smoking abstinence is measured using exhaled Carbon Monoxide (eCO) 12 months 2. Nicotine dependence is measured using Fagerstrom Test for Nicotine Dependence (FTND) at baseline and 6 months 3. Cigarette withdrawal symptoms is measured using Mood and Physical Symptoms Scale (MPSS) at baseline and 6 months 4. Quality of Life related to oral health is measured using Oral Health Quality of Life Assessment (OHQoL-UK) at baseline and 6 months. 5. Oral health is measured using Number of teeth at baseline and 6 months 6. Health economic evaluation (in terms of the following) is measured using Health Utilisation Questionnaire at baseline and 6 months 6.1. Costs to the NHS and participants 6.2. Incremental cost per smoking abstinence 6.3. Net monetary benefits based on participants’ willingness-to-pay for the intervention and associated outcomes 6.4. Incremental net benefit For periodontitis sub-group only 1. Periodontal health is measured using the following at baseline and 6 months 1.1. Percentage of periodontal sites with PPD (Pocket Probing Depths) =5 mm 1.2. Periodontal Epithelial Surface Area (PESA) 1.3. Periodontal Inflamed Surface Area (PISA) 2. Oral hygiene is measured using Plaque Index (PI) at baseline and 6 months 3. Gingival health is measured using the following at baseline and 6 months 3.1. Gingival Index [Lobene Modified Gingival Index] 3.2. Bleeding on Probing (BOP) 4. Dry mouth (as part of a routine oral health assessment) is measured using Clinical Oral Dryness Score at baseline and 6 months 5. Current and previous periodontal disease exposure is measured using clinical attachment loss (CAL) at baseline and 6 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed