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

Condition(s) targeted: Dental Pellicle

Intervention: 2 mg nicotine gum (Drug); 4 mg nicotine gum (Drug)

Phase: Phase 4

Status: Completed

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 Freshmint gum

Secondary outcome:

To assess reduction in tooth-staining in relation to usage of gums

To 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.

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

Starting date: July 2005
Ending date: September 2005
Last updated: March 27, 2008