Specialty: Oral and dental health, Primary sub-specialty: Oral and dental public health
Conditions
Interventions
Following assessment of eligibility and completion of informed consent participants will be randomised to one of two groups, in a 1:1 ratio using random permuted blocks. The randomisation allocation s
Sponsors
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years old 2. Smoker of burnt tobacco (=10 factory-made cigarettes/day or 7 g [0.25 oz] loose tobacco or 14 hand-rolled cigarettes/day) 3. Not currently using an EC, or not used one for more than two days in the last 30 days 4. Be willing and able to come to the Dental Clinical Research facility in the Newcastle Dental Hospital for the required study visits 5. Minimum of 20 natural teeth (excluding third molars) 6. Diagnosed with severe chronic periodontal disease having interproximal pocket probing depths (PPDs) of =5 mm at =8 teeth and BOP scores =30% 7. Have read, understood and signed an informed consent form
Exclusion criteria
Exclusion criteria: 1. Having used an e-cigarette for more than 2 days in the last 30 days 2. Infectious or systemic diseases that may be unduly affected by participation in this study 3. Haemodynamically unstable patients hospitalised with severe arrhythmias, myocardial infarction, cerebrovascular accident 4. Suffering from Phaeochromocytoma 5. Suffering from uncontrolled hyperthyroidism 6. Liver or Kidney problems 7. Chronic Obstructive Pulmonary Disease 8. Patients taking the medication Adenosine 9. Lack of capacity to be able to consent to the research project and/or inability to follow study instructions 10. Participation in a dental research study within the previous 20 days 11. Pregnant by medical history, or nursing 12. Received any non-surgical periodontal therapy other than a routine scale and polish in the last 6 months 13. Currently undergoing or requiring extensive dental, orthodontic or implant treatment, or treatment for peri-implantitis Eligibility Criteria requiring further discussions with individual participants: 1. Asthma (Severity needs to be assessed. Patient made aware that NRT better than smoking but best to use NRT as a short term stop smoking treatment). 2. Long term throat disease (Severity needs to be assessed. NRT use may exacerbate symptoms) 3. Stomach Ulcer, duodenal ulcer, irritation or inflammation of the stomach or throat (NRT may exacerbate symptoms) 4. Patient with diabetes mellitus will be advised to monitor their blood glucose more closely when initiating treatment. They will be advised to discuss this with their doctor or diabetic nurse. 5. Patients taking medications metabolised by CYP 1A2 and that have a narrow therapeutic window can be affected by stopping smoking. Patients taking theophylline, clozapine and ropinirole will be asked to see their doctor to discuss changing the dose prior to starting the quit attempt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Eligibility rate will be measured by examining screening records at the end of the study 2. Patients’ willingness to enter the trial will be measured by established by examining screening records at the end of the study and by the qualitative interviews 3. Recruitment rate will be measured by recording the number of eligible participant who consent to participate in the study by 12 months 4. Participation biases will be established by examining the screening/ recruitment data at the end of the study 5. Retention rate will be established by recording the number of participants who remain in the study until the end of follow up 6. Randomised group contamination rates (i.e. the extent of cross-over between the two arms of the trial) will be established by recording the e-cigarette use of all participants over the duration of the study 7. Periodontal Inflammed Surface Area [PISA] will be measured at baseline, 3-months and 6-months 8. Periodontal Epithelial Surface Area [PESA] will be measured at baseline, 3-months and 6-months 9. Pocket Probing Depths [PPDs]) will be measured at baseline, 3-months and 6-months 10. Distribution of microbiome is assessed using subgingival plaque samples at baseline, 3-months and 6-months 11. Distributional properties of the inflammatory biomarkers is assessed using subgingival plaque samples at baseline, 3-months and 6-months 12. Participant compliance with e-cigarette use is measured by self-reported feedback, weekly data collection and qualitative interviews 13. Tobacco smoking and e-cigarette usage is measured by self-reported feedback, weekly data collection and biochemical measurers 14. Participant behaviour regarding the use of the e-cigarette is established by qualitative interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed