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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT00174499
First received: September 12, 2005
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Dental Pellicle
Drug: 2 mg nicotine gum
Drug: 4 mg nicotine gum
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess reduction in tooth-staining in relation to usage of gums [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • To assess smoking status [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • To assess safety [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: July 2005
Study Completion Date: September 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174499

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

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT00174499     History of Changes
Other Study ID Numbers: A6431088
Study First Received: September 12, 2005
Last Updated: July 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Tooth stain

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

ClinicalTrials.gov processed this record on August 28, 2014