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

Overview

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.

Full Title of Study: “An Open-label Study on Nicorette Freshmint Gum, 2 MG AND 4 MG in Smokers With Visible Teeth Staining Motivated to Quit”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
• Study Primary Completion Date: August 2005

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.

Interventions

• Drug: 2 mg nicotine gum
  • 2 mg nicotine gum
• Drug: 4 mg nicotine gum
  • 4 mg nicotine gum

Arms, Groups and Cohorts

• Experimental: 1
  • 2 mg nicotine gum
• Experimental: 2
  • 4 mg nicotine gum

Clinical Trial Outcome Measures

Primary Measures

• 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

Secondary Measures

• To assess reduction in tooth-staining in relation to usage of gums
  • Time Frame: 6 Weeks
• To assess smoking status
  • Time Frame: 6 Weeks
• To assess safety
  • Time Frame: 6 Weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • McNeil AB
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Elisabeth A Kruse, PhD, Study Director, JJCPPW