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

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.

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment

Study Primary Completion Date: August 2005

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

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
    Safety Issue?: No

Secondary Measures

• To assess reduction in tooth-staining in relation to usage of gums
  • Time Frame: 6 Weeks
    Safety Issue?: No
• To assess smoking status
  • Time Frame: 6 Weeks
    Safety Issue?: No
• To assess safety
  • Time Frame: 6 Weeks
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Johnson & Johnson Consumer & Personal Products Worldwide

Overall Clinical Trial Officials and Contacts

Elisabeth A Kruse, PhD Study Director JJCPPW  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00174499

Study ID Number: A6431088

ClinicalTrials.gov Identifier: NCT00174499

Health Authority: United States: Institutional Review Board