Efficacy and Safety Evaluation of Jet Floss EX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The improvement in BOP(Bleeding on Probing) after 8 weeks of use.
研究概览
简要总结
This was a single center, comparison among treatments, 8-week study of the efficacy and safety of Jet Floss EX.
Totally 72 eligible subjects were recruited in this study and randomly divided into 2 groups. During wash out phase (7 days before the study), subjects used distributed manual toothbrush and toothpaste every morning and evening to replace their own products. After that, subjects screened by dentist to ensure met the inclusion criteria. During treatment phase, for group1 (treatment group), subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used the test product (Jet Floss EX) twice a day. For group2 (control group), subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used auxiliary product (interdental brush) twice a day. During the study, any other oral care products and non-emergency oral treatment were not allowed.
Test Objective:To evaluate the efficacy and safety of test product by means of intraoral exams of BOP, PD, MGI, RMNPI, hard and soft tissues exams and selfassessment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese men or women aged 18-60 years old;
- •In general good health at the time of the study;
- •Possess a minimum of 20 scorable teeth;
- •Each quadrant has ≥4 inter tooth gaps that can be inserted by interdental brush；
- •RMNPI≥0.6;
- •MGI≥1.75;
- •There were no diseases that will affect the test results;
- •Willing and able to participate as evidenced by signing of informed consent;
- •Willing to comply with all study protocol requirements.
排除标准
- •Intending to get pregnant, pregnant, lactating or within 6 months of delivery;
- •Those who have known allergies against oral care product or have severe oral disease;
- •Simultaneous participating in another oral study;
- •Have any fixed facial orthodontic appliances or removable partial dentures;
- •Severe presence of tartar or stain which will affect the test;
- •Others whose participation in the study is determined inappropriate by the dentist.
结局指标
主要结局
The improvement in BOP(Bleeding on Probing) after 8 weeks of use.
时间窗: 8 weeks
After 8 weeks of treatment, when compared with the baseline, reduction percentage in the bleeding index.
The improvement in MGI (Modified Gingival Index) after 8 weeks of use.
时间窗: 8 weeks
After 8 weeks of treatment, when compared with the baseline, reduction percentage in MGI (Modified Gingival Index).
The improvement in RMNPI (Rustogi Modification of the Navy Plaque Index) after 8 weeks of use.
时间窗: 8 weeks
After 8 weeks of treatment, when compared with the baseline, reduction percentage in RMNPI (Rustogi Modification of the Navy Plaque Index) .
次要结局
- Compare the differences in BOP(Bleeding on Probing) between the test group and the control group after 8 weeks of uses.(8 weeks)
- Compare the differences in PD (Probing Depth) between the test group and the control group after 8 weeks of uses.(8 weeks)
- Compare the differences in MGI (Modified Gingival Index) between the test group and the control group after 8 weeks of uses.(8 weeks)
- Compare the differences in RMNPI (Rustogi Modification of the Navy Plaque Index) between the test group and the control group after 8 weeks of uses.(8 weeks)
- Evaluate the safety of the test product(Jet Floss EX) by conducting an examination and assessment of the oral soft and hard tissues after 8 weeks of uses.(8 weeks)
- Subject satisfaction evaluation(8 weeks)