NCT00174499

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

September 12, 2005

Last Update Submit

July 6, 2012

Conditions

Dental Pellicle

Keywords

Tooth stain

Outcome Measures

Primary Outcomes (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

    6 Weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

2 mg nicotine gum

Drug: 2 mg nicotine gum

2

EXPERIMENTAL

4 mg nicotine gum

Drug: 4 mg nicotine gum

Interventions

2 mg nicotine gumDRUG

2 mg nicotine gum

Also known as: Nicorette Fresh Mint
1
4 mg nicotine gumDRUG

4 mg nicotine gum

Also known as: Nicorette Fresh Mint
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 20 natural teeth
  • inadequate oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Elisabeth A Kruse, PhD

    JJCPPW

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2005

Primary Completion

August 1, 2005

Study Completion

September 1, 2005

Last Updated

July 10, 2012

Record last verified: 2012-07