Erosion of Teeth, Unspecified Clinical Trial
Official title:
Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide: a Mono-centre, Not-controlled. Not Blinded, Not-randmised in Situ Study
| Verified date | August 2015 |
| Source | Mibelle AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Aeskulap Klinik | Brunnen |
| Lead Sponsor | Collaborator |
|---|---|
| Mibelle AG |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Detection of Curolox peptide by mass spectroscopy | 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 | Immediately after rinsing with the mouthwash | No |
| Secondary | Detection of Curolox peptide by mass spectroscopy | The secondary outcome is the detection of the Curolox™ peptide on the bovine enamel sample 12 hours, 24 hours, 48 hours and 96 hours after rinsing with the peptide-containing mouth wash by mass spectroscopy | 12 hours, 24 hours, 48 hours, 96 hours | No |