Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among Israeli Defence Force (IDF) Personnel
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).
研究概览
简要总结
Our study is designed as an interventional prospective longitudinal study which examines the Israeli defense force personnel. The population of our study is composed out of the IDF personnel which will be randomly be subdivided into 2 different groups - one will be noted as the intervention group and the other will function as a control group. Each participant will be monitored for a period of 18 months.
详细描述
On the intervention group, which includes a couple of hundreds participants, a thorough caries management by risk assessment plan will be conducted. The risk assessment will include the following criteria:
- Saliva check
- Plaque control
- Plaque acidity
- Diet - Frequency of carbohydrate intake
- Previous caries experience and present carious activity
- Others (prosthetic/orthodontic appliances, systemic diseases etc.)
After obtaining the data the patients will be categorized into 1 of 3 distinct risk level - low, medium, high. Each category will be treated according to a tailored treatment protocol:
- Dietary instructions
- Oral hygiene instructions
- Antibacterial therapy
- Fluorides
- Restoration
- Follow ups The control group will be treated according to standard protocol of treatment in the IDF dental clinics, which is based on removal the cavitated lesions, and lacks any reference to caries as a multifactorial infectious disease.
We assume that personalized treatment of the disease, based on identifying risk factors will lower the number of patients with active disease.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
排除标准
- •Pregnancy
- •Available for 18 month follow-up
结局指标
主要结局
Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).
时间窗: 6 months
次要结局
- Progression of the disease in 30% of patients in the control group in comparison to only 15% in the intervention group.(18 months)