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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001040-23 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Gum | Experimental | 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. |
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| Nicotine Microtab | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | Nicotine Gum 2 mg, Lot number GD922A |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Kruse, PhD | McNeil AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental School and Hospital, University College of Cork | Wilton | Cork | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22695211 | Derived | Whelton H, Kingston R, O'Mullane D, Nilsson F. Randomized controlled trial to evaluate tooth stain reduction with nicotine replacement gum during a smoking cessation program. BMC Oral Health. 2012 Jun 13;12:13. doi: 10.1186/1472-6831-12-13. |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Nicotine | Drug | Nicotine gum 4 mg, Lot number GC962A |
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| Nicotine | Drug | Nicotine Microtab 2 mg, Lot number GB196G |
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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 |
| D009057 | Stomatognathic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |