ICD-10 code Z72: ”Tobacco use not otherwise specified (NOS)” Respiratory Tobacco use
Conditions
Interventions
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
Sponsors
Swedish Match North Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Snus user, with a minimum weekly consumption of three or more snus 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of dental plaque acidogenicity, using the pH microtouch method, during exposure of nicotine pouch at baseline, one, two, 5, 10, 20, 30, 40, 50 and 60 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events are measured using patient interviews at screening, 0, 7, 14, 21 and 28 days (Part 1) or screening, baseline, 14, 28, 42 and 49 days (Part 2) 2. Oral microflora is measured using plaque sampling with a sterile toothpick from the buccal areas of respective quadrants at screening, 14, 28 and 42 days (Part 2) 3. Oral mucosa and pathological changes are recorded using the four-grade clinical scale measured using at screening, 14, 28 and 42 days (Part 2) | — |
Countries
Sweden
Outcome results
None listed