Malodour study to judge bad breath in subjects who smoke cigarettes compared to e-cigarette smokers and non-smokers

ISRCTN	ISRCTN17892113
DOI	https://doi.org/10.1186/ISRCTN17892113
Secondary identifying numbers	213418/GRD-PLN-1356

Submission date: 05/11/2018
Registration date: 20/11/2018
Last edited: 26/04/2021

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of this study is to find out whether vaping keeps the oral cavity (mouth) cleaner and healthier than conventional cigarettes and similar to that of non-smokers.

Who can participate?
Smokers, e-cigarette users and non-smokers aged 21-60

What does the study involve?
Participants are assessed by a dentist and have a breath sample taken. They are then asked to smoke their own cigarette or e-cigarette (or nothing for non-smokers) and provide breath samples again.

What are the possible benefits and risks of participating?
Participants can choose between being a non-smoker, e-cigarette user or conventional cigarette smoker depending on their results, and could benefit from healthier gums and soft palate tissue. There are no risks involved as participants will be using their own products and the sample measurements are non-invasive.

Where is the study run from?
Alba Science Ltd (UK)

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

Who is funding the study?
British American Tobacco (UK)

Who is the main contact?
Mr George Hardie

Contact information

Mr George Hardie
Scientific

R&D Centre, Regents Park Road
Southampton
SO15 8TL
United Kingdom

Study information

Study design	Single-centre oral evaluation study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Other
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Pilot study to determine the oral health and levels of volatile sulphur compounds (VSCs) in the breath of human volunteers before and after cigarette and e-cigarette product use, using SIFT-MS and OralChroma
Study objectives	To check if conventional cigarette smokers breath is more volatile compared to either e-cigarette users or non-smokers.
Ethics approval(s)	Reading Independent Ethics Committee, 17/10/2018, ref: RIEC091018-6
Health condition(s) or problem(s) studied	Oral health looking at effects on breath
Intervention	Collection of breath for analysis on SIFT-MS and OralChroma to detect for Volatile Sulphur Compounds and also to collect gingival crevicular fluid which will be identified and quantified for protein levels. Volunteers will be enrolled onto the clinical study after completing a form (informed consent) that they can understand, they will then be assessed for their oral health and be put forward to the in-life phase of the clinical study. Volunteers will be asked to have a baseline assessment completed by a dentist, then moved to another area of the clinical site to have a baseline breath sample taken. This sample will be analysed on a machine built to check on the identified criteria set out in the protocol. Volunteers will then be asked to smoke their own product cigarette, e-cigarette or nothing for non-smokers then are asked back to undertake breath samples similar to their baseline sample. Once complete volunteers will be released from the study and paid for their time as agreed when signing the informed consent form.
Intervention type	Other
Primary outcome measure	Measured from breath samples collected at baseline and after product use (or air in non-smokers): 1. Volatile Sulphur Compound levels, measured using SIFT-MS 2. Volatile Sulphur Compound levels, measured using OralChroma
Secondary outcome measures	1. Extrinsic tooth staining of 12 anterior teeth, measured using the Lobene Tooth Stain Index at screening/baseline 2. Protein analysis of gingival crevicular fluid (conducted by Sponsor), cytokines levels measured using Meso Scale Discovery multiplex assay kits in Timepoint 0 (T0) samples
Overall study start date	01/08/2018
Completion date	21/12/2018

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	137 subjects
Total final enrolment	33
Key inclusion criteria	1. Males or non-pregnant, non-lactating females, aged 21-60 years inclusive. Age verification will be performed by checking government issued identification (e.g. passport or driving licence) during screening 2. Good general health as judged by the Investigator or their appropriately qualified designee based on medical history 3. Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions. Subjects must demonstrate the ability to comprehend the Informed Consent Form (ICF), be able to communicate well with the Investigator or their appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator or their appropriately qualified designee 4. Subjects will be willing to refrain from consuming alcohol within 48 hours prior to Screening and study visit 5. Subjects will be willing to refrain from consuming coffee, onions, garlic and spicy food, for 48 hours prior to test visit 6. Good oral health with no diseases or conditions which could affect the study/have an adverse impact on the volunteer including severe gingivitis, grossly carious lesions and periodontal disease 7. At least 12 natural teeth, with at least 1 tooth suitable for GCF sampling (in the opinion of the dentist) per quadrant 8. No scale and polish for 6 months prior to screening for all groups 9. SMOKERS: 9.1. Subjects will be regular smokers of commercially manufactured filter cigarettes and including menthol cigarettes 9.2. Subjects will have smoked for at least 3 consecutive years prior to Screening 9.3. Subjects will typically smoke at least 10 cigarettes per day and an exhaled breath CO level ≥ 7 ppm at Screening measured using a CO meter 10. E-CIGARETTE USERS: 10.1. E-cigarette user of a minimum of 200 puffs per day or more for more than 6 months 10.2. Subjects are to be exclusive e-cigarette users for a minimum of 6 months, history of tobacco smoking and transition to e-cigarette to be documented 11. NON-SMOKERS: 11.1. Subjects will have never smoked (<100 cigarettes in their life and none within 1 year prior to Screening) and will continue to not smoke or use any form of tobacco or nicotine containing products for the duration of the study 11.2. Subjects with an exhaled breath CO level < 2 ppm at Screening
Key exclusion criteria	1. Signs of gross or untreated caries or of significant periodontal disease, which, in the opinion of the study dentist, either would affect the scientific validity of the study or, if the subject were to participate in the study, would affect their wellbeing 2. Orthodontic or prosthetic appliances (fixed or removable), including dental implants 3. Tongue or lip piercing 4. Currently participating in other dental trials 5. Pregnant or breastfeeding women 6. Medical condition and/or regular use of any medication which might affect the outcome of the study including: evidence or recent (within 4 weeks) history of bronchitis, tonsillitisor sinusitis, current respiratory infection, oesophageal reflux, colds, flu, sore throat, severe xerostomia, either self-reported or evidenced through oral examination, diabetics, current use or use of any antibiotics within 14 days prior to screening 7. Medications or supplements which may impact oral mouth odour within 7 days prior to the test visit, specifically zinc-containing products 8. Current use or use of anti-inflammatory medication within 4 weeks of screening 9. Subjects who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to Screening, as determined by the Investigator 10. Subjects who use “roll your own” or tobacco heating products 11. Subjects who use chewing tobacco or snuff 12. Subjects unable to attend for all visits 13. Employees and immediate relatives of the tobacco industry and the clinical site
Date of first enrolment	31/10/2018
Date of final enrolment	30/11/2018

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Alba Science Ltd

24 Broughton Street
Edinburgh
EH1 3RH
United Kingdom

Sponsor information

British American Tobacco
Industry

Regents Park Road
Southampton
SO15 8TL
United Kingdom

Website	www.bat-science.com
"ROR"	https://ror.org/01znsh139

Funders

Funder type

Industry

British American Tobacco
Private sector organisation / For-profit companies (industry)

Location: United Kingdom

Results and Publications

Intention to publish date	30/06/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	The protocol will be available, there is no SAP on this study. BAT are looking to publish this data mid 2019, results will be fully in the public domain.
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?
Protocol file		12/11/2019	26/04/2021	No	No

Additional files

ISRCTN17892113_PROTOCOL_12Nov2019.pdf: Uploaded 26/04/2021

Editorial Notes

26/04/2021: The following changes have been made:
1. Uploaded protocol, 12 November 2019 (not peer reviewed).
2. The total final enrolment number has been added.