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

Study Overview
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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.

Official Title
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An Open-label Study on Nicorette Freshmint Gum, 2 MG AND 4 MG in Smokers With Visible Teeth Staining Motivated to Quit

Conditions
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Dental Pellicle

Intervention / Treatment
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* Drug: 2 mg nicotine gum
* Drug: 4 mg nicotine gum


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2 mg nicotine gum | Drug: 2 mg nicotine gum<br>* 2 mg nicotine gum<br>* Other names: Nicorette Fresh Mint;|
| Experimental: 2<br>4 mg nicotine gum | Drug: 4 mg nicotine gum<br>* 4 mg nicotine gum<br>* Other names: Nicorette Fresh Mint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth stain