Erosion of Teeth, Unspecified
Conditions
Brief 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
Interventions
DEVICECandida Mouthwash with Curolox™ Peptide
Prophylaxis - protection and care of teeth against caries & acidic challenges
Sponsors
Mibelle AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Curolox peptide by mass spectroscopy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Curolox peptide by mass spectroscopy | 12 hours, 24 hours, 48 hours, 96 hours | 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 |
Countries
Switzerland
Outcome results
None listed