The Effect of Arginine on Biofilm Composition, Architecture and Metabolism in Caries-active Patients: a Split-mouth in Situ Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Biofilm pH
研究概览
简要总结
Arginine is an adjunct to oral health care that has the potential to modulate the composition and activity of the microbial community of dental biofilms towards a health-related status without harmful effects for the resident oral microbiota. The aim of the study is to investigate the effects of arginine treatment compared to placebo on the composition, metabolism, and microarchitecture of biofilms grown in situ in the oral cavity of caries-active participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Males and females ≥ 18 years old.
- •Three or more active carious lesions.
- •Anatomically possible to manufacture an intraoral lower-jaw splint.
- •Able to understand and follow instructions, as well as to read and sign the informed consent form.
排除标准
- •History of allergies towards any of the ingredients in the test products
- •Self-reported pregnant or nursing
- •Antibiotic or anti-inflammatory medication within 90 days of the screening visit.
- •Orthodontic appliances, including retainers, or removable partial dentures.
- •Self-reported serious medical conditions.
研究组 & 干预措施
Placebo
Placebo treatment is performed outside the oral cavity (ex vivo) by immersing one side of a splint into distilled water. Treatment is performed 3 times a day for 30 min.
干预措施: Placebo (Other)
Arginine solution
Arginine treatment is performed outside the oral cavity (ex vivo) by immersing one side of a splint into a solution of arginine 1.5% (w/v). Treatment is performed 3 times a day for 30 min.
干预措施: Arginine (Other)
结局指标
主要结局
Biofilm pH
时间窗: Measured after in situ biofilm growth
Extracellular biofilm pH measured after sucrose challenge using pH ratiometry
次要结局
- Biofilm microbial composition(Analyzed after in situ biofilm growth)
- Biofilm thickness(Measured after in situ biofilm growth)
- Biofilm matrix architecture(Analyzed after of in situ biofilm growth)