Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination Phase I
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol
研究概览
简要总结
To evaluate the anti-bacterial, pre-procedural, clinical efficacy of Peroxyl mouthwash (1.5% hydrogen peroxide) in saliva and the reduction of bioaerosol contamination as compared to a matching placebo mouthwash (0.0% hydrogen peroxide)
详细描述
Qualified subjects will be enrolled and randomized to either one of the two study groups, balanced on the basis of their initial gingival index scores. Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. All collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis.
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
- Double (Participant, Investigator)
盲法说明
A blinded randomized controlled parallel group design trial
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
- •Potential subjects must meet ALL of the following criteria:
- •Subjects, ages 18-70, inclusive.
- •Availability for the duration of this clinical research study.
- •Good general health.
- •At least 20 natural teeth.
- •Gingivitis Index 1.0 (Löe-Silness).
- •Signed Informed Consent Form
排除标准
- •Potential subjects must NOT HAVE ANY of the following conditions:
- •Symptoms consistent with COVID-19 or have tested positive.
- •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) or peri-implantitis.
- •Five or more carious lesions requiring immediate restorative treatment.
- •Use of antibiotic 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.
- •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.
- •An existing medical condition that prohibits not eating or drinking for periods up to 4 hours.
- •History of alcohol or drug abuse.
- •Self-reported pregnant or lactating subjects.
研究组 & 干预措施
placebo mouthwash
0.0% Hydrogen peroxide mouthwash
干预措施: Placebo Mouthwash (Drug)
Peroxyl
1.5% Hydrogen Peroxide mouthwash
干预措施: Peroxyl Mouthwash (Drug)
结局指标
主要结局
Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol
时间窗: baseline, 30 minutes & 60 minutes
Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. All collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis.
次要结局
未报告次要终点