Impact of nicotine use on oral health, dental caries Oral Health
Conditions
Interventions
Investigational products (IPs) to choose from in treatment arm 1:
ZYN Dry Smooth, containing 6 mg nicotine per pouch
ZYN Dry Cool Mint, containing 6 mg nicotine per pouch
ZYN Dry Citrus, containing 6
Sponsors
Swedish Match North Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give written informed consent for participation in the study. 2. Have used tobacco-based snus for =1 year, with a minimum weekly consumption of =3 cans, and =90% of the total nicotine consumption should have been tobacco-based snus 3. Non-smoker (have smoked =5 packages in total ever and have not smoked at all during the last year) 4. Healthy male or female subject aged =21 to =55 years 5. Normal stimulated salivary secretion rate (>0.7 ml/min) 6. At least 24 own teeth remaining and overall good oral health, as judged by the Investigator 7. Subjects of child-bearing potential must be willing to use a sufficient contraceptive method for the duration of the study. This includes mechanical barrier (e.g. a male condom or a female diaphragm), combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal anticonception associated with inhibition of ovulation (oral, injectable, implantable), intra uterine device (IUD) or intra uterine system (IUS). Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
Exclusion criteria
Exclusion criteria: 1. History of diagnosed hypertension or any cardiovascular disease, or ongoing manifestations of hypertension or any cardiovascular disease as judged by the Investigator 2. Any surgical or medical condition, including abnormal salivation (also pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the IP, or may either put the subject at risk because of participation in the study, influence the results, or the subject’s ability to participate in the study 3. Subjects who are pregnant, breastfeeding, or intend to become pregnant during the course of the study 4. History of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavorings), as judged by the Investigator 5. Severe oral conditions such as open caries lesions, severe periodontal health, lesions in the soft tissues (apart from gingival hyperplasia related to the use of snus), or extensive prosthetic work (e.g. several implants, partial denture, dental veneers). 6. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the Investigator 7. Antibiotic use =4 weeks prior to the screening period 8. Subjects who intend to change their nicotine consumption habit, including the intention to stop using nicotine products, within the next 4 months of the screening visit, as judged by the Investigator 9. Subjects undergoing other dental treatment during the study period 10. The Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in dental plaque acidogenicity measured using pH in plaques on two buccal surfaces in the upper jaw, one approximal surface in the upper jaw, and one approximal surface in the lower jaw before and up to 60 min after a 1 min mouth rinse with 10 mL of a 10% sucrose solution at -28, 0, 14, and 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference in dental plaque acidogenicity measured using pH in plaques at -28, 0, 14, and 28 days 2. The difference in the counted number of cariogenic microorganisms in dental plaque measured using a count of the number of colony-forming units of pooled plaque samples collected with a sterile toothpick from buccal areas and plated on agar plates for analyses of the number of microorganisms related to caries and periodontal diseases (and for assessment of gene expression levels to analyse a broader range of cariogenic microorganisms) at -28, 0, 14, and 28 days 3. The difference in the amount of plaque measured using a count of the amount of plaque on all surfaces of the Ramfjord teeth (16, 21, 24, 36, 41, and 46) and scoring 0-3 of six sites of each tooth for plaque at -28, 0, 14, and 28 days 4. The difference in the degree of oral mucosal lesions by presence, visual grading, and histopathological evaluation of biopsies measured using: 4.1. Assessment and grading (1-4) of gingival hyperplasia from visual assessment and clinical photos taken at -28, 0, 14, and 28 days 4.2. Histopathological evaluation and diagnosis of punch biopsy (4 mm in diameter, fixed in 10% formaldehyde, processed, mounted on glass slides, and stained) from the oral mucosa, where the pouch previously was placed, collected at 0 and 28 days 5. The difference in tooth discoloration, measured using a colorimeter and by visual shade grading using a shade guide of the maxillary and mandibular anterior teeth performed at -28, 0 (before and after cleaning the teeth with rotating rubber cup and polishing paste), and 28 days 6. Safety measured using the frequency, intensity, and seriousness of adverse events (AEs) collected by subject interview between 0 (the start of IP administration, Visit 3) and 28 (the last treatment visit, Visit 5) days | — |
Countries
Sweden
Outcome results
None listed