A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining

Study Overview
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Brief Summary
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Participants will be smokers who want to quit, and have visible nicotine stains on their teeth. They will be given toothpaste and a toothbrush to use during the study, and will have an equal chance of being assigned to use either a nicotine gum or microtab. They will visit the study site five times during the 12 week trial to have their teeth examined.

Detailed Description
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This evaluator-blinded, randomized, 12-week parallel-group controlled trial compares Nicorette® Freshmint gum versus Nicorette® Microtab in healthy smokers who are motivated to quit smoking and who have visible staining of teeth. The trial is comprised of five visits (baseline, Weeks 1, 2, 6, and 12). At baseline, subjects will be provided with a standardized toothpaste and toothbrush; use of any other oral hygiene or tooth-whitening product is prohibited. At all visits after baseline, smoking status and use of study treatment will be checked. Teeth staining and teeth shade will be rated at baseline and at 2, 6 and 12 Weeks using the Modified Lobene Stain Index and the Vita® Shade Guide, respectively.

Official Title
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An Evaluator-Blinded, Randomized, Parallel Controlled Study of Nicorette® Freshmint Gum Versus Nicorette® Microtab in Healthy Smokers Motivated to Quit Smoking With Visible Staining of Teeth

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Nicotine
* Drug: Nicotine
* Drug: Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18 to 65 years Daily smoker, current daily smoking for at least 1 year Motivated to quit smoking, and willing to use NRT (nicotine gum or nicotine sublingual tablet) Normal chewing abilities (able to use chewing gum without any problems) Willing to refrain from dental prophylaxis for the duration of the 12-week trial Have a minimum of 20 natural teeth, with at least 10 of the 12 anterior teeth present and scorable. Have a total extrinsic facial tooth stain score equal or more than 28, according to the MacPherson Modification of the Lobene Stain Index. Willing and able to comply with scheduled visits, treatment plan, tests, and other trial procedures. Exclusion Criteria: Use of other tobacco-containing products, such as cigars, pipe, smokeless tobacco products, etc. Existing use of any nicotine replacement products for smoking cessation, or undergoing any other treatment for tobacco dependence, such as hypnosis, acupuncture, bupropion, etc. Orthodontic appliances Gross periodontal disease, or signs of gross oral neglect History of oral cancer History of temporomandibular joint disorders known to aggravate jaw pain Unstable angina pectoris or myocardial infarction during the previous 3 months Pregnancy, lactation or intended pregnancy Any major metabolic disease, clinically important renal or hepatic disease Suspected alcohol or drug abuse Participation in another clinical trial within the previous three months and during study participation Any other severe acute or chronic medical or psychiatric condition that might increase the risk associated with trial participation or trial drug administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, makes the subject inappropriate for entry into this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Gum<br>After being randomized to the gum or tablet, dosage will be based on baseline level of nicotine dependence. Highly dependent smokers will receive nicotine 4 mg gum, while low nicotine-dependent smokers will receive nicotine 2 mg gum to help them quit. Subjects will be advised to use the treatment frequently, according to the product labeling, in order to minimize or avoid symptoms of tobacco withdrawal. Study medication will be used for 12 weeks. | Drug: Nicotine<br>* Nicotine Gum 2 mg, Lot number GD922A<br>* Other names: Nicorette® Freshmint Gum;Drug: Nicotine<br>* Nicotine gum 4 mg, Lot number GC962A<br>* Other names: Nicorette® Freshmint Gum;|
| Active Comparator: Nicotine Microtab<br>After being randomized to the gum or tablet, subjects will receive instructions according to their baseline level of nicotine dependence. Highly dependent smokers will be instructed to use a 4 mg dosage of the Microtab (2 x 2 mg tablets), while low nicotine-dependent smokers will be instructed to use a 2 mg dosage of the Microtab to help them quit. Subjects will be advised to use the treatment frequently, according to the product labeling, in order to minimize or avoid symptoms of tobacco withdrawal. Study medication will be used for 12 weeks. | Drug: Nicotine<br>* Nicotine Microtab 2 mg, Lot number GB196G<br>* Other names: Nicorette® Microtab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Total Extrinsic Tooth Stain Score | Mean change in total extrinsic tooth stain score, for the whole mouth region. Extrinsic tooth staining is measured using the MacPherson Modification of the Lobene Stain Index. A lower stain index score represents a reduction in extrinsic tooth staining. | Baseline, 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Total Extrinsic Tooth Stain Score | Mean change in total extrinsic tooth stain score, for the whole mouth region, measured using the MacPherson Modification of the Lobene Stain Index. A lower stain index score represents a reduction in extrinsic tooth staining. | Baseline, 2 Weeks | 
| Change from Baseline in Total Extrinsic Tooth Stain Score | Mean change in total extrinsic tooth stain score, for the whole mouth region, measured using the MacPherson Modification of the Lobene Stain Index. A lower stain index score represents a reduction in extrinsic tooth staining. | Baseline, 12 Weeks | 
| Change from Baseline in Mean Stain Index Facial Region | Mean changes in the extrinsic facial surface stain score between baseline and Weeks 2, 6 and 12. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Index Lingual Region | Mean changes in the extrinsic lingual surface stain score between baseline and 2, 6 and 12 weeks. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Index Body Region | Mean changes in the extrinsic body region stain scores between baseline and 2, 6 and 12 weeks. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Index Gingival Region | Mean changes in the extrinsic gingival region stain scores between baseline and 2, 6 and 12 weeks. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Index Interproximal Region | Mean changes in the extrinsic interproximal region stain scores between baseline and 2, 6 and 12 weeks. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Area Total Region | Mean stain area between baseline and Weeks 2, 6 and 12 for the facial region, lingual region, body region, gingival region, and interproximal region (Total Region). | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Area Facial Region | Mean stain area between baseline and Weeks 2, 6 and 12 for the facial region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Area Lingual Region | Mean stain area between baseline and Weeks 2, 6 and 12 for the lingual region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Area Body Region | Mean stain area between baseline and Weeks 2, 6 and 12 for the body region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Area Gingival Region | Mean stain area between baseline and Weeks 2, 6 and 12 for the gingival region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Area Interproximal Region | Mean stain area between baseline and Weeks 2, 6 and 12 for the interproximal region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Intensity Total Region | Mean stain intensity between baseline and Weeks 2, 6 and 12 for the facial region, lingual region, body region, gingival region, and interproximal region (Total Region). | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Intensity Facial Region | Mean stain intensity between baseline and Weeks 2, 6 and 12 for the facial region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Intensity Lingual Region | Mean stain intensity between baseline and Weeks 2, 6 and 12 for the lingual region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Intensity Body Region | Mean stain intensity between baseline and Weeks 2, 6 and 12 for the body region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Intensity Gingival Region | Mean stain intensity between baseline and Weeks 2, 6 and 12 for the gingival region. | Baseline through Week 12 | 
| Change from Baseline in Mean Stain Intensity Interproximal Region | Mean stain intensity between baseline and Weeks 2, 6 and 12 for the interproximal region. | Baseline through Week 12 | 
| Change from Baseline in Mean Tooth Shade | Mean tooth shade between baseline and Weeks 2, 6, and 12 using the Vita® Shade Guide. A higher number represents a lighter tooth shade. | Baseline through Week 12 | 

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