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

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ClinicalTrials.gov Identifier: NCT00174499
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Pellicle Drug: 2 mg nicotine gum Drug: 4 mg nicotine gum Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : July 2005
Primary Completion Date : August 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
2 mg nicotine gum
Drug: 2 mg nicotine gum
2 mg nicotine gum
Other Name: Nicorette Fresh Mint
Experimental: 2
4 mg nicotine gum
Drug: 4 mg nicotine gum
4 mg nicotine gum
Other Name: Nicorette Fresh Mint

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To assess reduction in tooth-staining in relation to usage of gums [ Time Frame: 6 Weeks ]
  2. To assess smoking status [ Time Frame: 6 Weeks ]
  3. To assess safety [ Time Frame: 6 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174499

Sponsors and Collaborators
McNeil AB
Study Director: Elisabeth A Kruse, PhD JJCPPW
More Information

Responsible Party: McNeil AB
ClinicalTrials.gov Identifier: NCT00174499     History of Changes
Other Study ID Numbers: A6431088
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ):
Tooth stain

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action