Preventive Effect of an Enzyme-containing Lozenge on Dental Biofilm Accumulation in Healthy Individuals: A Clinical Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Accumulation of dental plaque after 24 hours
研究概览
简要总结
The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.
详细描述
The purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. The null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy males and females ≥18 years of age.
- •Able to read, sign and receive a copy of the signed informed consent form.
- •Have at least 20 natural teeth.
排除标准
- •Clinically visible active caries lesions and/or periodontitis.
- •Significant oral soft tissue pathology based on a visual examination.
- •History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
- •History of allergies to ingredients in the test product.
- •History of allergies towards enzymes.
- •Self-reported as pregnant or nursing.
- •Self-reported serious medical conditions.
- •Antibiotic or anti-inflammatory medication within 30 days of screening visit.
- •Orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures.
- •Acute sinusitis or severe oral-pharyngeal infections.
结局指标
主要结局
Accumulation of dental plaque after 24 hours
时间窗: Change in dental plaque score from baseline to 24 hours' follow-up
Dental plaque assessed by the modified Quigley-Hein Plaque Index
次要结局
- Development of gingivitis after 7 days(Change in gingivitis score from baseline to 7 days' follow-up)
- Microbial characterization of the oral microbiome from plaque and saliva samples(7 days' follow-up)
- Accumulation of dental plaque after 7 days(Change in dental plaque score from baseline to 7 days' follow-up)