Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions: A Mono-centre, Split-mouth, Double-blinded, Placebo Controlled, Randomised, Post Marketing Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Credentis AG
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary efficacy outcome is the difference of the change in the lesion size assessed by morphometry (standardised pictures) between investigational medical device and placebo group.
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early buccal carious lesions compared to placebo.
详细描述
All study participants must have two early class V carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and one with placebo as control (single application). 3 months later fluoride (Duraphat) will be applied on both lesions. Study duration is 9 months. For assessment visual and tactile evaluation, pictures, ECM, Diagnodent Pen, Canary System, VAS is used.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two class V carious lesions which do not require an invasive treatment
- •Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
- •Patients must be able and willing to observe good oral hygiene throughout the study
- •≥ 20 teeth
- •Permanent dentition and ≤ 65 years
- •Willing and able to attend the on-study visits
- •Willing and able to understand all study-related procedures
- •Written informed consent before participation in the study
- •Negative pregnancy test for women of childbearing potential
排除标准
- •The two study lesions must not be on adjacent teeth
- •No adjacent restoration on study tooth surface
- •Fluoride varnish application < 6 months prior to study treatment
- •Patient suffers from diabetes
- •Evidence of tooth erosion (due to excessive acidic drink consumption or reflux)
- •History of head and neck illnesses (e.g. head/neck cancer)
- •Any pathology or concomitant medication affecting salivary flow or dry mouth
- •Any metabolic disorders affecting bone turnover
- •Concurrent participation in another clinical trial with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry
- •Pregnant and lactating woman
结局指标
主要结局
The primary efficacy outcome is the difference of the change in the lesion size assessed by morphometry (standardised pictures) between investigational medical device and placebo group.
时间窗: D0, D30, D90, D270
Change of lesion size relative to baseline between study groups and different time points
次要结局
- Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.(D0, D30, D90, D180, D270)
- Change in lesion's progression assessed by VAS between investigational medical device and placebo group.(D0, D30, D90, D180, D270)