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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from Baseline in Total Extrinsic Tooth Stain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nicotine Gum
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.
干预措施: Nicotine (Drug)
Nicotine Microtab
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.
干预措施: Nicotine (Drug)
结局指标
主要结局
Change from Baseline in Total Extrinsic Tooth Stain Score
时间窗: Baseline, 6 Weeks
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.
次要结局
- Change from Baseline in Total Extrinsic Tooth Stain Score(Baseline, 12 Weeks)
- Change from Baseline in Mean Stain Index Facial Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Index Lingual Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Index Body Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Index Gingival Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Index Interproximal Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Area Total Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Area Facial Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Area Lingual Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Area Body Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Area Gingival Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Area Interproximal Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Intensity Total Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Intensity Facial Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Intensity Lingual Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Intensity Body Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Intensity Gingival Region(Baseline through Week 12)
- Change from Baseline in Mean Stain Intensity Interproximal Region(Baseline through Week 12)
- Change from Baseline in Mean Tooth Shade(Baseline through Week 12)