Determination of Anti-Plaque and Anti-Gingivitis Efficacy of One Experimental Mouthrinse Following a Baseline Oral Prophylaxis: A Four Week Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Whole-mouth Mean Plaque Index (PI)
研究概览
简要总结
This study will test the idea that using an experimental mouth rinse after each time you brush your teeth will result in a healthier mouth than using the regular mouth rinse. Participants will be expected to avoid oral hygiene (like brushing teeth or using mouthwash) for at least 12 hours before each visit and will not be allowed to eat, drink or smoke for at least 4 hours before each visit.
At the first visit, the study will be explained to you in detail and you will be allowed to ask any questions you may have before signing a consent form. You will complete a medical/dental history and the dentist will examine your mouth, during which he will poke your gums and scrape some plaque off your teeth for testing. If you do not meet the requirements to continue in the trial, you will be told that you do not need to return for more testing.
If you meet requirements to continue, you will have an equal chance of being assigned to use either of the two mouth rinses being studied. You will be given a diary, toothbrush, toothpaste, and your assigned mouth rinse, with instructions on how they must be used.
You will be instructed not to use any unassigned oral care products and to follow your usual eating habits. You will be given appointments to return two times within the next four weeks. At those visits, the staff will check to make sure you're following the instructions and ask how you're feeling, and the dentist will do the same thing he did during the first visit.
详细描述
The primary objective of this randomized, double-blind, single-center, controlled, parallel-designed clinical study is to determine the efficacy of an experimental mouth rinse on whole-mouth mean plaque and gingivitis scores as an adjunct to brushing after four weeks of use.
The secondary objectives will be to determine the efficacy of the an experimental mouth rinse as an adjunct to brushing on whole-mouth mean plaque and gingivitis measured at 2 weeks as well as a bleeding assessment according to the Bleeding Index at 2 and 4 weeks. A microbiological assessment will be performed to identify and quantify specific oral microbes to assess any change in population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females at least 18 years of age and in good general health.
- •Must display adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
- •Volunteers must read, sign, and receive a copy of the Informed Consent Form after the nature of the study has been fully explained.
- •Must be willing to use the products according to instructions and be available for appointments.
- •Baseline dental measurements meet protocol-specified criteria.
- •Willingness to refrain from using all oral hygiene procedures within 12-18 hours prior to each visit.
- •Refrain from eating, drinking or smoking for four hours prior to each visit.
排除标准
- •Lip, tongue, or other form of oral piercing.
- •Fixed or removable orthodontic appliance (such as bridges, braces or dentures).
- •Pregnancy or breast-feeding at any time during the trial.
- •Any medical, dental or psychiatric condition, abnormality or history, or use of any product or drug, that (per protocol or in the opinion of the investigator) may increase the risk to the subject associated with trial participation or investigational product administration, or interfere with the interpretation of trial results.
研究组 & 干预措施
0.15% ethyl lauroyl arginate HCl-containing mouthrinse
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
干预措施: 19416-154-1 (Device)
5% hydroalcohol mouthrinse
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
干预措施: W002194-0221P (Device)
结局指标
主要结局
Whole-mouth Mean Plaque Index (PI)
时间窗: 4 weeks
Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.
Whole-mouth Mean Modified Gingival Index (MGI)
时间窗: 4 weeks
Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index (MGI) where 0=Normal and 4=Severe Inflammation.
次要结局
- Whole-mouth Mean Modified Gingival Index (MGI)(2 weeks)
- Microbiological Assessments - LOG Counts(4 weeks)
- Microbiological Assessments - Absolute Counts(4 weeks)
- Whole-mouth Mean Plaque Index (PI)(2 Weeks)
- Whole-mouth Mean Bleeding Index (BI)(4 Weeks)
- Whole-mouth Mean Bleeding Index (BI)(2 Weeks)