A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum
Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Pellicle
Intervention: 2 mg nicotine gum (Drug); 4 mg nicotine gum (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: McNeil AB Official(s) and/or principal investigator(s): Elisabeth A Kruse, PhD, Study Director, Affiliation: JJCPPW
Summary
The purpose of this research study is to evaluate the effects on existing tooth stain of
nicotine gum. The study will enroll adults who have visible tooth staining.
Clinical Details
Official title: An Open-label Study on Nicorette Freshmint Gum, 2 MG AND 4 MG in Smokers With Visible Teeth Staining Motivated to Quit
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: The primary objective of this study was to assess, by using the MacPherson modification of the Lobene Stain Index, the amount of extrinsic tooth-stain reduction from Baseline while quitting smoking using Nicorette Freshmint gum
Secondary outcome: To assess reduction in tooth-staining in relation to usage of gumsTo assess smoking status To assess safety
Detailed description:
This was a 6-week, open-label, single-center study conducted in 78 subjects who were smokers
with visible staining of teeth and who were motivated to quit smoking through use of
Nicorette Freshmint gum.
The subjects were assigned, per label instructions, to either Nicorette Freshmint gum 2 mg
or 4 mg based on the number of cigarettes smoked per day. Subjects who smoked at least 25 or
more cigarettes per day were assigned to the 4 mg gum group; those who smoked less than 25
cigarettes per day were assigned to the 2 mg gum group.
A total of 3 study visits were planned: Screening/Baseline, Week 2 and Week 6. A telephone
screening prior to Baseline and the Screening/Baseline visit was performed to confirm
subject eligibility. At each visit an oral examination, including a stain index measurement
used to rate tooth-staining (MacPherson Modification of the Lobene Stain Index), was
conducted; and smoking status and motivation to quit smoking were assessed. The safety
evaluation at each visit included an oral tissue assessment in addition to assessment for
any adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- daily smokers for at least one year
- motivated to quit smoking
- normal chewing ability
- willing to refrain from a dental prophylaxis for the duration of the study
- total extrinsic facial tooth stain score > or = to 28, according to the MacPherson
Modification of the Lobene Stain Index
Exclusion Criteria:
- < 20 natural teeth
- inadequate oral hygiene
Locations and Contacts
Additional Information
Starting date: July 2005
Last updated: July 6, 2012
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