NCT02308436

Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide

Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide: a Mono-centre, Not-controlled. Not Blinded, Not-randmised in Situ Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mibelle AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: 1. safety and tolerance of the mouthwash in participants 2. identification of the duration the Curolox™ peptide is present on the bovine tooth surface under in vivo conditions 3. identification of the most effective mouthwash rinsing volume (2.5 mL or 5 mL) 4. prophylactic effect of multiple applications of the mouthwash confirmation of the prophylactic effect of the Curolox™ peptide obtained in in vitro study

Conditions

• Erosion of Teeth, Unspecified

Interventions

Type	Name	Description
DEVICE	Candida Mouthwash with Curolox™ Peptide	Prophylaxis - protection and care of teeth against caries \& acidic challenges

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-12-04
• Last updated: 2015-08-28

Locations

1 site across 1 country: Switzerland