A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum

• 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 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  

• To assess reduction in tooth-staining in relation to usage of gums [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  
• To assess smoking status [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  
• To assess safety [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  

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.