Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Three-month Study in Italy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Modified Gingival Index
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 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 two weeks, six weeks and 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.
- •Initial modified gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index.
- •Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.
- •Signed Informed Consent Form (Appendix C)
排除标准
- •Presence of 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.
- •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.
研究组 & 干预措施
Test 1 mouthwash
After brushing in the morning and in the evening, 20 ml of mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time. No further rinsing with water shall be occurred after each mouthwash rising. Each qualified subject will follow this specific application for 3 months
干预措施: cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash (Drug)
Test 2 mouthwash
After brushing either in the morning or in the evening, 20 ml of the mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time
干预措施: sodium fluoride Mouthwash (Drug)
结局指标
主要结局
Modified Gingival Index
时间窗: baseline, 2 week, 6 week & 3 month
A Modified Gingivitis Index score from 0 to 4 will be assigned by the examiner to all tooth surfaces. In regards to the scale, lower number is a better outcome.
Saxton Bleeding Index
时间窗: baseline, 2 week, 6 week & 3 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, 2 week, 6 week & 3 month
Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces. In regards to the scale, lower number is a better outcome.
Modified Gingival Index
时间窗: baseline, 2 week, 6 week & 6 month
A Modified Gingivitis Index score from 0 to 4 will be assigned by the examiner to all tooth surfaces. In regards to the scale, lower number is a better outcome.
次要结局
未报告次要终点