An interventional study of Candida Mouthwash with Curolox™ Peptide in Erosion of Teeth, Unspecified, sponsored by Mibelle AG. Withdrawn at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-28.
Sponsored by Mibelle AG · Not applicable, Interventional, and Prevention
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:
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
Browse Tooth Erosion studies →Mibelle AG is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Repeated applications 2.5 ml or 5 ml twice daily
Device: Candida Mouthwash with Curolox™ Peptide
Prophylaxis - protection and care of teeth against caries \& acidic challenges
Also known as: Candida Protect
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
The record gives a start of Feb 2015, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Mibelle AG