Feasibility study of e-cigarettes in periodontitis

ISRCTN	ISRCTN17731903
DOI	https://doi.org/10.1186/ISRCTN17731903
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	CPMS 32034
Sponsor	Newcastle Upon Tyne Hospitals NHS Foundation Trust
Funder	National Institute for Health Research

Submission date: 19/09/2016
Registration date: 27/09/2016
Last edited: 10/10/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Tobacco smoking is well known to have negative effects on oral health. In particular, smoking dramatically increases the risk of developing gum (periodontal) disease, which can lead to tooth loss. Dentists therefore play a role in helping patients to stop smoking and provide stop smoking advice to their patients. Electronic cigarettes (e-cigarettes) are increasing in popularity and there is growing evidence they may be an effective way to help people give up smoking. With several million users of e-cigarettes in the UK it is important that dentists understand the role they may play in helping their patients to stop smoking. However, there is no research to show their usefulness within the dental setting and any potential effects for oral health, particularly periodontal health. The aim of this study is to investigate the effect of e-cigarettes on periodontal health, in order to find out whether a large scale study would be possible.

Who can participate?
Smokers over 18 years old who have been diagnosed with severe, long-term gum disease.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive usual stop smoking advice from the dentist. Participants in the second group receive usual stop smoking advice from the dentist as well as an e-cigarette starter kit and brief training on how to use it. Participants in both groups then receive normal periodontal therapies delivered over several appointments. A sample of the participants is also asked to attend 1-3 additional visits so they can be interviewed about their experiences in the study. The amount of participants taking part is recorded in order to find out whether a larger scale study would be possible.

What are the possible benefits and risks of participating?
As participants in this study receive periodontal therapies, they may see significant improvements to their gum health. Participants also benefit from receiving help with quitting smoking, which will hopefully help reduce smoking levels which is beneficial for general and oral health. There are no known risks involved with participating.

Where is the study run from?
Newcastle Dental Hospital (UK)

When is the study starting and how long is it expected to run for?
December 2015 to November 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Richard Holliday
richard.holliday@newcastle.ac.uk

Contact information

Dr Richard Holliday
Scientific

D4.016
Newcastle Dental Hospital
Richardson Road
Newcastle Upon Tyne
NE2 4AZ
United Kingdom

ORCID ID	0000-0002-9072-8083
Phone	+44 191 233 6161 (ext 26812)
Email	richard.holliday@newcastle.ac.uk

Study information

Primary study design	Interventional
Study design	Randomized; Interventional; Design type: Treatment, Prevention, Complex Intervention
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A mixed methods feasibility study of electronic cigarette use by patients with periodontitis
Study objectives	The aim of this study is to assess the viability of delivering and studying an e-cigarette intervention prior to a definitive study.
Ethics approval(s)	North East - Tyne & Wear South Research Ethics Committee, 03/08/2016, ref: 16/NE/0219
Health condition(s) or problem(s) studied	Specialty: Oral and dental health, Primary sub-specialty: Oral and dental public health; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of oral cavity, salivary glands and jaws
Intervention	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 schedule will be generated by a statistician with no other involvement in the study to achieve concealment of allocation. Control group: Participants receive standard stop smoking advice from the dentist. This involves the ‘3 A’s’: Ask, Advise, Act technique and the option of a referral to Newcastle stop smoking services. Intervention group: Participants receive the same standard stop smoking advice from the dentist as the control group but are also given an e-cigarette starter kit and given brief training on its use. For all participants, follow up involves normal periodontal therapies delivered over several appointments. A sample of the participants will be asked to attend 1-3 additional visits for qualitative interviews about their experiences in the study.
Intervention type	Other
Primary outcome measure(s)	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 15. A Qualitative Process Evaluation will establish the views of participants on the provision of e-cigarettes and to finalise the exact characteristics of an e-cigarette intervention for the future definitive study for this patient group
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	30/11/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Total final enrolment	80
Key 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
Key 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.
Date of first enrolment	20/09/2016
Date of final enrolment	19/09/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Newcastle Dental Hospital

Richardson Road
Newcastle upon Tyne
NE2 4AZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/06/2019	10/06/2019	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan		04/06/2019	10/10/2023	No	No

Editorial Notes

10/10/2023: Statistical analysis plan added.
10/06/2019: Publication reference and total final enrolment added.