A Six-month Clinical Investigation of a Silica-free Meridol Toothpaste Versus Colgate Cavity Protection Toothpaste for the Control of Established Dental Plaque and Gingivitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Gingivitis Assessment
研究概览
简要总结
The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.
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 six-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.
研究组 & 干预措施
Test 1 toothpaste
Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.
干预措施: Silica Free Meridol (Drug)
Test 2 toothpaste
Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.
干预措施: Meridol (Drug)
Test 3 toothpaste
Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.
干预措施: Colgate Dental Product (Drug)
结局指标
主要结局
Gingivitis Assessment
时间窗: Baseline, 3 month, 6 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. 0 = Absence of inflammation 1. = Mild inflammation - slight change in color and little change in texture 2. = Moderate inflammation - moderate glazing, redness, edema and hypertrophy 3. = Severe inflammation - marked redness and hypertrophy. Tendency for spontaneous bleeding Each tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. The maximum score per tooth, therefore, is 18.
Quigley-Hein Plaque Index
时间窗: Baseline, 3 month, 6 month
First using a red solution to dye the plaque, 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