Plain English Summary
Background and study aims
Smokers have worse gum disease and are more likely to lose teeth than non-smokers. When smokers stop smoking, the condition of their gums changes and become similar to a non-smoker. E-cigarettes contain nicotine and are gaining popularity, but we do not know what e-cigarettes do to the gums. We plan to study the gum condition of smokers with mild gum disease who stop smoking cigarettes for 2 weeks and use e-cigarettes instead. Gum disease can change the amount of certain chemicals in the blood, saliva and the fluid that collects in the crevice between the gum and the tooth. The amount of those chemicals changes when people stop smoking, but we do not know what happens to them when e-cigarettes are used.
Who can participate?
Smokers with mild gum disease who do not intend to quit smoking but would be prepared to substitute e-cigarettes instead of smoking for 2 weeks
What does the study involve?
We measure the gum condition of a group of smokers who do not intend to quit smoking. We also take blood from a vein in the arm, collect saliva and the fluid that collects in the crevice between the gum and the tooth. The smokers stop smoking cigarettes for 2 weeks and we provide e-cigarettes for them to use instead. After 2 weeks we measure the gum condition again and collect samples of blood, saliva and gum fluid again.
What are the possible benefits and risks of participating?
There are no particular benefits for people who take part except to try out e-cigarettes at no cost to themselves. There are also no particular risks except minor discomfort during the gum examination and during collection of blood.
Where is the study run from?
King's College London (UK)
When is the study starting and how long is it expected to run for?
November 2014 to July 2016
Who is funding the study?
King's College London (UK)
Who is the main contact?
Dr Veronica Booth
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
161226
Study information
Scientific title
Changes in the gingival condition and inflammatory mediators of smokers who substitute the use of e-cigarettes for their regular smoking habits.
Acronym
Study hypothesis
There will be no change in the gingival condition of smokers after 2 weeks of substituting e-cigarette use for normal smoking habits.
Secondary objectives of the project are to compare the concentrations of inflammatory markers in the saliva, gingival crevicular fluid and the plasma after cigarette smoking and e-cigarette use.
Ethics approval
NRES Committee London - London Bridge, 23/01/2015, ref: 14/LO/2092
Study design
Single-centre longitudinal pilot study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gingival inflammation
Intervention
The study involves smokers with mild periodontal (gum) disease who do not intend to quit smoking but would be prepared to substitute e-cigarettes instead of smoking for 2 weeks. The aim would be to compare gum inflammation in the smokers when smoking cigarettes with their condition after using e-cigarettes for 2 weeks. Subjects would provide samples of saliva and the gingival crevicular fluid that collects in the crevice between the gums & and teeth (GCF) and also venous blood. Examining the biochemical markers of inflammation within blood, saliva & GCF would help to determine whether the substitution of e-cigarettes modifies the subjects' inflammatory response in mild periodontal disease.
Intervention type
Other
Phase
Drug names
Primary outcome measures
The number of gingival sites bleeding after probing, measured at baseline and 2 weeks
Secondary outcome measures
1. The volume of gingival crevicular fluid, measured at baseline and 2 weeks
2. The concentration of biomarkers in plasma and gingival crevicular fluid, measured at baseline and 2 weeks
Overall trial start date
06/11/2014
Overall trial end date
31/07/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subjects must have at least 24 natural teeth, excluding third molars
2. Subjects must have smoked at least 5 cigarettes/day for at least 5 years
3. They will be systemically healthy individuals who have mild periodontal disease with no pocket depth over 5 mm at any site
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Subjects with any systemic condition known to exacerbate or modulate periodontal disease e.g., diabetes
2. Have taken antibiotics in the previous 3 months
3. Take any anti-inflammatory drugs regularly
4. Take other medication likely to affect the periodontal tissue e.g., calcium channel blocking drugs
5. Pregnant or nursing mothers
6. Patients with nut allergies will be excluded as the nicotine-containing fluid may contain traces of nuts
Recruitment start date
27/04/2015
Recruitment end date
04/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
Guy's & St Thomas's Hospital
Floor 21
Tower Wing
London
SE1 9RT
United Kingdom
Funders
Funder type
University/education
Funder name
Kings College London
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
M.Clin Dent. project to be submitted by 31/07/2016
Intention to publish date
31/07/2016
Participant level data
Not expected to be available
Results - basic reporting
Publication summary