Clinical Research Study to Assess the Efficacy of Two Brushing Regimens: 1) a Toothpaste Containing Stannous Fluoride With a Mouthwash Containing Cetylpyridinium Chloride and a Manual Toothbrush as Compared to 2) a Regular Fluoride Toothpaste and Standard Manual Toothbrush in the Reduction of Established Dental Plaque and Gingivitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Quigley and Hein Plaque Index
研究概览
简要总结
Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1-, 3-, 6-, and 12-weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form.
- •Male and female subjects aged 18-70 years, inclusive.
- •Availability for the twelve-week duration of the clinical research study.
- •Good general health based on the opinion of the study investigator
- •Minimum of 20 permanent natural teeth (excluding third molars).
- •Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
- •Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification)
排除标准
- •Presence of orthodontic appliances.
- •Presence of partial removable dentures.
- •Tumor(s) of the soft or hard tissues of the oral cavity.
- •Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
- •Five or more carious lesions requiring immediate restorative treatment.
- •Antibiotic use any time during the one-month period prior to entry into the study.
- •Participation in any other clinical study or test panel within the one month prior to entry into the study.
- •Dental prophylaxis during the past two weeks prior to baseline examinations.
- •History of allergies to oral care/personal care consumer products or their ingredients.
- •On any prescription medicines that might interfere with the study outcome.
- •An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
- •History of alcohol and/or drug abuse.
- •Self-reported pregnancy and/or lactating subjects
研究组 & 干预措施
Group I
manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) Brush 2 x day / 2 mins Colgate Total Mouthwash (CPC+Zn) Swish 20 mL / 30 secs
干预措施: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) (Drug)
Group I
manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) Brush 2 x day / 2 mins Colgate Total Mouthwash (CPC+Zn) Swish 20 mL / 30 secs
干预措施: manual toothbrush + Colgate dental cream (Drug)
Group II
Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins
干预措施: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) (Drug)
Group II
Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins
干预措施: manual toothbrush + Colgate dental cream (Drug)
结局指标
主要结局
Quigley and Hein Plaque Index
时间窗: Baseline, 1-, 3-, 6-, and 12-week
reductions in dental plaque
Loe and Silness Gingival Index
时间窗: Baseline, 1-, 3-, 6-, and 12-week
reductions in gingivitis
次要结局
未报告次要终点