Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Effectiveness of the oral rinse in reducing plaque
研究概览
简要总结
Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath
详细描述
This clinical study design is a randomized, double-blind, single-treatment, parallel design with a placebo as the control. Following a screening exam, the duration of the trial will be 1 month. Oral examinations will occur at Visit 1 (baseline), and Visit 2 (4 weeks post screening). Also, at these visits, subjects will be asked keep a diary for the one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness". They will also be asked about the taste and consistency of the mouth rinse. Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). Gingival health will be measured using the Modified Gingival Index (MGI)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
- •Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
- •Subject is between the ages of 18 and 75 years inclusive.
- •Subject will not have professional cleaning during the study.
- •Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
- •Subject has a minimum of 12 natural teeth.
- •Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Aim® Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
- •Subject agrees to refrain from the use of other oral care products not supplied by the study center
- •Subject agrees to be compliant with study procedures.
- •Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy
排除标准
- •Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
- •Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
- •Subject is between the ages of 18 and 75 years inclusive.
- •Subject will not have professional cleaning during the study.
- •Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
- •Subject has a minimum of 12 natural teeth.
- •Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Aim® Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
- •Subject agrees to refrain from the use of other oral care products not supplied by the study center
- •Subject agrees to be compliant with study procedures.
- •Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy testing at the first and second visit.
结局指标
主要结局
Effectiveness of the oral rinse in reducing plaque
时间窗: 4 weeks
Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI).
Effectiveness of the oral rinse in reducing gingivitis
时间窗: 4 weeks
Gingival health will be measured using the Modified Gingival Index (MGI)
Effectiveness of the oral rinse in improving a patient's breath
时间窗: 4 weeks
Subjects will be asked keep a diary for one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness",
次要结局
- Safety evaluation of the test Oral Rinse(4 weeks)