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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Prophylaxis - protection and care of teeth against caries \& acidic challenges
Aeskulap Klinik
Brunnen, Switzerland
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
Time frame: Immediately after rinsing with the mouthwash
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
Time frame: 12 hours, 24 hours, 48 hours, 96 hours
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