Changes in the gum condition of smokers who substitute the use of e-cigarettes for their regular smoking habits
| ISRCTN | ISRCTN17182047 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17182047 |
| Secondary identifying numbers | 161226 |
- Submission date
- 03/02/2016
- Registration date
- 05/02/2016
- Last edited
- 01/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Floor 21
Guy's Tower Wing
Great Maze Pond
London Bridge
London
SE1 9RT
United Kingdom
Study information
| Study design | Single-centre longitudinal pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Changes in the gingival condition and inflammatory mediators of smokers who substitute the use of e-cigarettes for their regular smoking habits. |
| Study objectives | 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(s) | NRES Committee London - London Bridge, 23/01/2015, ref: 14/LO/2092 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 06/11/2014 |
| Completion date | 31/07/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/04/2015 |
| Date of final enrolment | 04/12/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Floor 21
Tower Wing
London
SE1 9RT
United Kingdom
Sponsor information
University/education
Room 1.1
Hodgkin Building
Guy's Campus
London Bridge
London
SE1 1UL
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- King's College, King's College London UK, KCL, King's
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | M.Clin Dent. project to be submitted by 31/07/2016 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2016 | 01/07/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/07/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
