An open observational study investigating the effect on oral health when using tobacco free nicotine pods

Not Applicable

Completed

• Conditions: ICD-10 code Z72: ”Tobacco use not otherwise specified (NOS)”; Respiratory; Tobacco use

• Registration Number: ISRCTN16087707
• Lead Sponsor: Swedish Match North Europe

Brief Summary

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35853092/ Effects on mucosal lesions and cytokine levels (added 25/07/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-28
• Study Completion: 2019-03-21
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified