Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Split-mouth, Post-marketing Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Credentis AG
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Opaqueness on X-Ray
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 approximal carious lesions compared to fluoride.
详细描述
All study participants must have two early approximal 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 fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two approximal carious lesions on different teeth with at least one tooth in between
- •Both study lesions must not require an invasive treatment
- •Size and form of the lesions: the lesions must be fully visible and assessable on radiographs
- •The two carious lesions must fall into classes:
- •D2 (inner half of enamel)
- •D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)
- •Able and willing to observe good oral hygiene throughout the study
- •Age ≥ 18 years 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
排除标准
- •The two study test lesions are located on adjacent teeth
- •Fluoride varnish application < 3 months prior to study treatment
- •Tooth with numerous carious lesions
- •Evidence of tooth erosion
- •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
- •Patient suffers from diabetes
- •Concurrent participation in another clinical trial
- •Women who are breast-feeding, pregnant or who plan a pregnancy during the study
- •Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
研究组 & 干预措施
Fluoride
Application on Day 0, Day 180, Day 360, Day 540
干预措施: Fluoride (Device)
Curodont Repair
Application on Day 0 and Day 360
干预措施: Curodont Repair (Device)
结局指标
主要结局
Opaqueness on X-Ray
时间窗: Day 360
The primary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 0 to Day 365 between test and control group.
次要结局
- Additional benefit of a second Curodont Repair application(Day 720)