Effect of Enzyme-containing Lozenges on Dental Biofilm Accumulation in Healthy Individuals: A Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Plaque amount
研究概览
简要总结
The purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults.
详细描述
The purpose of the study is to examine the clinical effects of lozenges containing three extracellular matrix-degrading enzymes on dental plaque accumulation and removal, prevention of gingivitis, and oral microbiome composition after professional tooth cleaning, as compared to a placebo lozenge without enzymes. Two different concentrations of the enzymes will be tested, to investigate a potential dose-dependent effect of the enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral mucosa. The null hypothesis is that treatment with enzyme-containing lozenges does 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
- Quadruple (Participant, Care Provider, 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.
- •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
Plaque amount
时间窗: Change in QHPI score from baseline to 24 hours' follow-up
Dental plaque accumulation after 1-day use of either a test or placebo investigational lozenge assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque)
次要结局
- Gingivitis(Change in GI from baseline to Day 14 follow-up)
- Plaque fluorescence intensity measurement(Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up)
- Plaque amount(Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up)
- Plaque removal(Day 14 visit)
- Oral microbiome(Change in microbiome composition from baseline to Day 14 follow-up)