Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- incidence of new caries lesions
研究概览
简要总结
Basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. For this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. This is especially true in high caries risk populations and more so for young adults who stand to benefit the most from working towards a caries free adulthood.
详细描述
Aim of the study: is to conduct an RCT to compare the effectiveness of a new personalized caries-control treatment protocol with standard caries treatment protocol for reducing caries incidence in high caries risk patients
Hypothesis
This project will be designed to test the null hypothesis that there is no significant difference between the new personalized caries-control treatment protocol and existing standard caries treatment protocol, and to test the alternative hypothesis that the new personalized treatment protocol will be superior to the standard preventive measures
Primary objective: is to measure the incidence of new caries lesions
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
- Double (Participant, Outcomes Assessor)
盲法说明
The recruiter will be blinded. The operator cannot be blinded because of the different in the procedures of caries prevention applied in each group. However, the assessors will be kept unaware of the treatment assigned to the patient.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High caries risk patients
- •18-25 years
- •Males or Females
- •Patients approving to participate in the study -
排除标准
- •Patients with systemic conditions
- •Current periodontitis (sites of probing pocket depth ≥ 5 mm)
- •Allergy to any of the ingredients of the study products
- •Evidence of parafunctional habits
- •Dysfunction of temporomandibular joint
- •Use of antibiotics in the previous 30 days
- •Patients with developmental dental anomalies
- •Patients with removable prosthesis
- •Patients with Orthodontic appliance
- •Periapical Abscess or Fistula and exposed pulps.
研究组 & 干预措施
Personalized Treatment
Intervention by (standard preventive measures + targeting individual caries risk factors)
干预措施: Personalized Treatment (Other)
Chlorhexidine and Rremineralization
Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures)
干预措施: Chlorhexidine and Remineralization (Other)
Control
standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning)
干预措施: Control (Other)
结局指标
主要结局
incidence of new caries lesions
时间窗: 12 month
incidence of new caries lesions
次要结局
未报告次要终点
研究者
Sherif Khadr
Doctoral Candidate
Cairo University