A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum
Information source: Johnson & Johnson Consumer & Personal Products Worldwide
Information obtained from ClinicalTrials.gov on June 20, 2008
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
Sponsored by: Johnson & Johnson Consumer & Personal Products Worldwide
Official(s) and/or principal investigator(s):
Elisabeth A Kruse, PhD, Study Director, Affiliation: JJCPPW
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.
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: Other, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
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
To assess reduction in tooth-staining in relation to usage of gums
To assess smoking status
To assess safety
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- < 20 natural teeth
- inadequate oral hygiene
Locations and Contacts
Starting date: July 2005
Ending date: September 2005
Last updated: March 27, 2008