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

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 Overview

• Status: Completed
• Conditions: Dental Pellicle
• Intervention / Treatment: Drug: 2 mg nicotine gum; Drug: 4 mg nicotine gum

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; 2 mg nicotine gum	Drug: 2 mg nicotine gum; 2 mg nicotine gum; Other Names: Nicorette Fresh Mint
EXPERIMENTAL: 2; 4 mg nicotine gum	Drug: 4 mg nicotine gum; 4 mg nicotine gum; Other Names: Nicorette Fresh Mint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McNeil AB

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (ACTUAL): August 1, 2005
• Study Completion (ACTUAL): September 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (ESTIMATE): September 15, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Tooth stain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: A6431088