Condition category
Oral Health
Date applied
19/09/2016
Date assigned
27/09/2016
Last edited
27/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Holliday

ORCID ID

http://orcid.org/0000-0002-9072-8083

Contact details

D4.016
Newcastle Dental Hospital
Richardson Road
Newcastle Upon Tyne
NE2 4AZ
United Kingdom
+44 191 233 6161 (ext 26812)
richard.holliday@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32034

Study information

Scientific title

A mixed methods feasibility study of electronic cigarette use by patients with periodontitis

Acronym

Study hypothesis

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

North East - Tyne & Wear South Research Ethics Committee, 03/08/2016, ref: 16/NE/0219

Study design

Randomised; Interventional; Design type: Treatment, Prevention, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/12/2015

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years old
2. Smoker of burnt tobacco (≥10 factory-made cigarettes/day or 7g [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 ≥ 5mm at ≥ 8 teeth and BOP scores ≥ 30%
7. Have read, understood and signed an informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

1. Having used an e-cigarette for more than two 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 will their doctor or diabetic nurse.
5.Patients taking medications metabolised by CYP 1A2 and that have a narrow therapeutic window can be effected 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.

Recruitment start date

20/09/2016

Recruitment end date

19/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle Dental Hospital
Richardson Road
Newcastle upon Tyne
NE2 4AZ
United Kingdom

Sponsor information

Organisation

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Freeman Hospital
Freeman Road
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The findings of this research will be disseminated locally (at departmental meetings), and nationally and internationally via presentations at research conferences. The results of the research will be written up for submission for publication in peer reviewed national and international journals. It is likely that the findings of this research will be of interest to the general public, and Newcastle University has an established press office for communicating findings of research to the press in an appropriate format.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

30/11/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes