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

• Register: ISRCTN
• Last refreshed on: 27 February 2024
• Main ID: ISRCTN16087707
• Date of registration: 28/11/2017
• Prospective Registration: No
• Primary sponsor: Swedish Match North Europe
• Public title: An open observational study investigating the effect on oral health when using tobacco free nicotine pods
• Scientific title: 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
• Date of first enrolment: 06/11/2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN16087707
• Study type: Interventional
• Study design: Part 1: Single-centre open randomized four-way crossover single administration trial including 20 subjects Part 2: Single-centre open observational follow-up study during 6 weeks including 60 subjects (Other)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Camilla Pramfalk

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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.

Primary Outcome(s)

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 Outcome(s)

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)

Secondary ID(s)

SM 17-02

Source(s) of Monetary Support

Swedish Match North Europe

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; EPN Gothenburg, 24/10/2017, ref: Dnr 778-17

Results

• Date Completed: 21/03/2019