Malodour study to judge bad breath in subjects who smoke cigarettes compared to e-cigarette smokers and non-smokers
- Conditions
- Oral health looking at effects on breathOral Health
- Registration Number
- ISRCTN17892113
- Lead Sponsor
- British American Tobacco
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Measured from breath samples collected at baseline and after product use (or air in non-smokers):<br> 1. Volatile Sulphur Compound levels, measured using SIFT-MS<br> 2. Volatile Sulphur Compound levels, measured using OralChroma<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Extrinsic tooth staining of 12 anterior teeth, measured using the Lobene Tooth Stain Index at screening/baseline<br> 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<br>