Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination Phase 2
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
- evaluate the antibacterial efficacy of mouthwash in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis
研究概览
简要总结
To evaluate the antibacterial efficacy of a commercial mouthwash containing 1.5% hydrogen peroxide in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis.
详细描述
Following a washout period, subjects will return to the clinical site. A baseline microbial sample will be collected from the operatory's atmosphere for 30 min. prior to the study subject appointment by placing blood agar plates on a support board attached to the bracket chair tray. Upon completion of a half-mouth (e.g. right side) dental prophylaxis, each study subject will be instructed to rinse for one minute with 10 ml of one of the two mouthwash solutions (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) and to expectorate all remaining liquid. Next, the dental prophylaxis will be completed on the other side of the mouth. Bioaerosol samples will be collected prior to and following rinsing on blood agar plates placed on a support board at a 50-degree angle to the participant's chest, on the participant's chest, and on the examiner's forehead. Plates will be closed and labeled. The plates will be transferred to the microbiology laboratory for analysis. 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcome 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
- •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
Peroxyl
Drug: Peroxyl Mouthwash Mouthwash
Other Names:
• 1.5% HP
干预措施: Peroxyl Oral Product (Drug)
placebo mouthwash
Drug: Placebo Mouthwash Mouthwash
Other Names:
• 0.0% HP Mouthwash
干预措施: Placebo (Drug)
结局指标
主要结局
evaluate the antibacterial efficacy of mouthwash in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis
时间窗: 30 min
baseline microbial sample will be collected from the operatory's atmosphere for 30 min. prior to the study subject appointment by placing blood agar plates on a support board attached to the bracket chair tray. Upon completion of a half-mouth (e.g. right side) dental prophylaxis, each study subject will be instructed to rinse for one minute with 10 ml of one of the two mouthwash solutions (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) and to expectorate all remaining liquid. Next, the dental prophylaxis will be completed on the other side of the mouth. Bioaerosol samples will be collected prior to and following rinsing on blood agar plates placed on a support board at a 50-degree angle to the participant's chest, on the participant's chest, and on the examiner's forehead. Plates will be closed and labeled. The plates will be transferred to the microbiology laboratory for analysis
次要结局
未报告次要终点