Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- bacteria in biofilm
研究概览
简要总结
Oral dysbiosis systematically develops during orthodontic treatment [35][36]. Orthodontic appliances interfere with oral hygiene procedures and cause biofilm to accumulate, creating new retention zones, even in subjects who maintain correct oral hygiene [37]:
- A group benefiting from intensive personalised prevention
- A "conventionally monitored" group, with no personalised prevention. The hypothesis is that personalised prevention prevents dysbiosis from taking hold. If this hypothesis is confirmed, the concept could be extended to all patients, beyond orthodontics.
Based on the "biological signature" (microbiological and immune), a "risk profile" of patients could be defined, making it possible to better personalise the prevention message, the method applied and the frequency of follow-up. The aim would be to rebalance dysbiosis through a personalised prevention approach tailored to the profile defined.
It was decided to explore this hypothesis initially with orthodontic patients because they are "captive", i.e. in the course of treatment requiring regular visits. Prevention is aimed first and foremost at healthy patients, with the aim of maintaining them in good health. The project focuses on young patients undergoing orthodontic treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.
排除标准
- •Overcrowded restorations, untreated caries,
- •lack of tooth mineralisation;
- •Medical pathologies;
- •Known immunodepression (congenital or acquired);
- •Taking a treatment that may induce general immunodepression;
- •Taking a probiotic;
- •Taking a concomitant treatment that may interact with oral health
研究组 & 干预措施
patient with standard care
patient with standard care
干预措施: Standard Care Arm (Other)
patient with standard care combined with personalised prevention
patient with standard care combined with personalised prevention
干预措施: standard care combined with personalised prevention (Other)
结局指标
主要结局
bacteria in biofilm
时间窗: At 12 months
number of pathogenic bacteria measured in the biofilm
viruses in biofilm
时间窗: At 12 months
number of viruses measured in the biofilm
bacteria in biofilm
时间窗: At inclusion
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
时间窗: At 3 months
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
时间窗: At 6 months
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
时间窗: At 9 months
number of pathogenic bacteria measured in the biofilm
viruses in biofilm
时间窗: At inclusion
number of viruses measured in the biofilm
viruses in biofilm
时间窗: At 3 months
number of viruses measured in the biofilm
viruses in biofilm
时间窗: At 6 months
number of viruses measured in the biofilm
viruses in biofilm
时间窗: At 9 months
number of viruses measured in the biofilm
次要结局
- patient's satisfaction(at 12 months)
- measurement of immune response(At 12 months)
- plaque index(through study completion, an average of 1 year)
- gingival index,(through study completion, an average of 1 year)
- toothbrush wear(through study completion, an average of 1 year)
- measurement of immune response(At inclusion)
- measurement of immune response(At 3 months)
- measurement of immune response(At 6 months)
- measurement of immune response(At 9 months)