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Study is not realised.
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In vitro results showed a protective effect against acids for the mouthwash containing Curoloxâ„¢ peptide. The goal of this in situ study is to detect the Curoloxâ„¢ 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 Curoloxâ„¢ mouthwash under natural oral conditions available.
The primary objective of the study is the detection of the Curoloxâ„¢ 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candida Mouthwash with Curoloxâ„¢ Peptide | Experimental | Repeated applications 2.5 ml or 5 ml twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candida Mouthwash with Curoloxâ„¢ Peptide | Device | Prophylaxis - protection and care of teeth against caries & acidic challenges |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Curolox peptide by mass spectroscopy | The primary outcome is the detection of the Curoloxâ„¢ peptide on the bovine enamel sample immediately after rinsing with the peptide-containing mouth wash by mass spectroscopy | Immediately after rinsing with the mouthwash |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Curolox peptide by mass spectroscopy | The secondary outcome is the detection of the Curoloxâ„¢ 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Besimo, Dr.med.dent. | Aeskulap Klinik | Principal Investigator |
| Ulrich P. Saxer, Dr.med.dent. | Aeskulap Klinik / PZZN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aeskulap Klinik | Brunnen | Switzerland |
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| ID | Term |
|---|---|
| D014077 | Tooth Erosion |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
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