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

NCT ID: NCT00174499

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Pellicle

Keywords

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Tooth stain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

2 mg nicotine gum

Group Type EXPERIMENTAL

2 mg nicotine gum

Intervention Type DRUG

2 mg nicotine gum

2

4 mg nicotine gum

Group Type EXPERIMENTAL

4 mg nicotine gum

Intervention Type DRUG

4 mg nicotine gum

Interventions

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2 mg nicotine gum

2 mg nicotine gum

Intervention Type DRUG

4 mg nicotine gum

4 mg nicotine gum

Intervention Type DRUG

Other Intervention Names

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Nicorette Fresh Mint Nicorette Fresh Mint

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McNeil AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth A Kruse, PhD

Role: STUDY_DIRECTOR

JJCPPW

Other Identifiers

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A6431088

Identifier Type: -

Identifier Source: org_study_id