Clinical Evaluation of a Stannous Fluoride Toothpaste Versus a 67% Bicarbonate Toothpaste and Colgate Cavity Protection Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems: a Six-month Clinical Study in Italy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Lobene Modified Gingivitis Assessment
研究概览
简要总结
Qualified subjects will be enrolled and randomized to either one of the three study groups described above based on their initial modified gingivitis and plaque 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 and six 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
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
randomized
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 study.
- •Good general health.
- •Initial gingivitis index of at least 1.5 as determined by the use of the Modified Gingivitis Index.
- •Initial plaque index of at least 1.5 as determined by the use of the Modified Quigley-Hein Plaque Index.
- •Signed Informed Consent Form
排除标准
- •Orthodontic bands.
- •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
- •Use of antibiotics 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.
- •Received a dental prophylaxis in the two weeks prior to your initial examination.
- •History of allergies to oral care/personal care consumer products or their ingredients.
- •Having taken any prescription medicines that might interfere with the study outcome.
- •If you with an existing medical condition which prohibits you from not eating or drinking for periods of up to 4 hours.
- •Self-reported pregnant or breast feeding an infant.
- •History of drug abuse
研究组 & 干预措施
Test 1 toothpaste
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time
干预措施: 0.45% SnF HW with NaF (1450 F) (Drug)
Positive Control
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time
干预措施: 67% Bicarbonate with NaF (1400 F) (Drug)
Negative Control
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time
干预措施: Colgate Cavity Protection Toothpaste (Drug)
结局指标
主要结局
Lobene Modified Gingivitis Assessment
时间窗: Baseline, 3 month, 6 month
Modified Gingivitis Index score from 0 to 4 will be assigned by the examining dentist to all tooth surfaces 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
Saxton Gingival Bleeding Assessment
时间窗: Baseline, 3 month, 6 month
Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding, a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing
Modified Quigley-Hein Plaque Index
时间窗: Baseline, 3 month, 6 month
First using a red dye solution to disclose the plaque, a Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces 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