The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis (A Three Month Clinical Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Loe-Silness Gingival Index score
研究概览
简要总结
Qualified subjects will be enrolled and randomized to either one of the two study groups described above 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 three months of product use. 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects, ages 18-70, inclusive.
- •Availability for the three-month duration of the clinical research study.
- •Good general health.
- •Minimum of 20 uncrowned 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).
- •Signed Informed Consent Form
排除标准
- •Presence of orthodontic bands.
- •Presence of partial removable dentures.
- •Tumor(s) of the soft or hard tissues of the oral cavity.
- •Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- •Five or more carious lesions requiring immediate restorative treatment.
- •Antibiotic use any time during the one month 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 which prohibits eating or drinking for periods up to 4 hours.
- •History of alcohol or drug abuse.
- •Pregnant or lactating subjects
研究组 & 干预措施
Colgate Cavity Protection Toothpaste
toothpaste
干预措施: MFP Fluoride toothpaste (Drug)
Colgate Dual Zinc Toothpaste
toothpaste
干预措施: zinc containing toothpaste (Drug)
结局指标
主要结局
Loe-Silness Gingival Index score
时间窗: baseline, 2 week, 6 week, 3 month
A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.
Quigley-Hein Plaque Index score
时间窗: baseline, 2 week, 6 week, 3 month
A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.
次要结局
未报告次要终点