Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide: a Mono-centre, Not-controlled. Not Blinded, Not-randmised in Situ Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mibelle AG
- 试验地点
- 1
- 主要终点
- Detection of Curolox peptide by mass spectroscopy
研究概览
简要总结
In vitro results showed a protective effect against acids for the mouthwash containing Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under natural oral conditions on the tooth surface and to proof the in vitro results obtained. So far there are no effect and safety data of the Curolox™ mouthwash under natural oral conditions available.
详细描述
The primary objective of the study is the detection of the Curolox™ peptide on the bovine enamel sample (proof-of-concept) under in vivo conditions after rinsing with the peptide-containing mouth wash.
Secondary Objectives
The secondary objectives of the study are:
- safety and tolerance of the mouthwash in participants
- identification of the duration the Curolox™ peptide is present on the bovine tooth surface under in vivo conditions
- identification of the most effective mouthwash rinsing volume (2.5 mL or 5 mL)
- prophylactic effect of multiple applications of the mouthwash confirmation of the prophylactic effect of the Curolox™ peptide obtained in in vitro study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- 是
入选标准
- •Willing and able to understand and to follow the study procedures and instructions
- •Willing to wear a dental appliance for 7 days
- •Willing and able to attend the on-study visits
- •Good oral hygiene throughout the study
- •Written informed consent before participation in the study
排除标准
- •Volunteer with an active periodontal disease or periodontal surgery < 1 year prior to study participation
- •Volunteer with hypersensitive teeth or with any other (painful) oral pathology or defect
- •Volunteer with an orthodontic appliance
- •Volunteer undergoing a medical treatment
- •Volunteer who is allergic to dental products
- •Pregnant and lactating woman
- •Concurrent participation in another clinical trial
研究组 & 干预措施
Candida Mouthwash with Curolox™ Peptide
Repeated applications 2.5 ml or 5 ml twice daily
干预措施: Candida Mouthwash with Curolox™ Peptide (Device)
结局指标
主要结局
Detection of Curolox peptide by mass spectroscopy
时间窗: Immediately after rinsing with the mouthwash
The primary outcome is the detection of the Curolox™ peptide on the bovine enamel sample immediately after rinsing with the peptide-containing mouth wash by mass spectroscopy
次要结局
- Detection of Curolox peptide by mass spectroscopy(12 hours, 24 hours, 48 hours, 96 hours)