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

British American Tobacco0 sites33 target enrollmentNovember 20, 2018

ConditionsOral health looking at effects on breath Oral Health

Overview

Phase: 未知
Intervention: Not specified
Conditions: Oral health looking at effects on breath
Sponsor: British American Tobacco
Enrollment: 33
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 20, 2018

End Date

December 21, 2018

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

British American Tobacco

Eligibility Criteria

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

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