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
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.
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
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention