Oral Safety Study: Open observational study of oral health associated with use of a non-tobacco based nicotine pouch (ZYN®) among current daily snus users
ICD-10 code Z72: ”Tobacco use not otherwise specified (NOS)”
This study contains two parts. The first part of the study assessed the dental plaque acidogenicity after short-term exposure to study protocols. Part 1: Participants are randomly allocated in four ways in this cross over trial: 1. ZYN® Smooth 3 mg 2. ZYN® Peppermint 3 mg 3. 10% sucrose 4. 10% xylitol The treatments are administered as single doses in a pre-determined computer-generated randomized order according to a four sequence list. The subject keeps the pouch still between the upper lip and the gum for 60 minutes. The duration of the treatments and follow-up takes approximately 30 days. Part 2: Ad libitum use of a ZYN® nicotine pouch, participants can choose from 3 or 6 mg pouches of ZYN® Smooth, ZYN® Peppermint or ZYN® Cinnamon. The treatments are administered as ad libitum use during 6 weeks. Subjects will report to the clinic every second week for oral assessments. Each visit takes approximately 75 minutes.
1. Snus user, with a minimum weekly consumption of three or more snus cans (brands with nicotine content <1%) or two or more cans (brands with nicotine content >1%) since ≥1 year 2. Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure 3. Healthy male/female, age ≥19. Female subjects should have a negative pregnancy test 4. Willing and able to comply with study procedures 5. Normal stimulated salivary secretion rate (>0.7 ml/min)
1. A history or presence of diagnosed hypertension or any cardiovascular disease 2. Surgery within 6 months of the screening visit that, in the opinion of the investigator, could negatively impact on the subject’s participation in the clinical study 3. Any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of nicotine 4. Subjects who are pregnant 5. Allergy towards composite materials 6. Antibiotic use during or within the last 4 weeks prior to the study period