Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide

Study Overview
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Brief Summary
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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
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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: safety and tolerance of the mouthwash in participants identification of the duration the Curolox™ peptide is present on the bovine tooth surface under in vivo conditions identification of the most effective mouthwash rinsing volume (2.5 mL or 5 mL) prophylactic effect of multiple applications of the mouthwash confirmation of the prophylactic effect of the Curolox™ peptide obtained in in vitro study

Official Title
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Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide: a Mono-centre, Not-controlled. Not Blinded, Not-randmised in Situ Study

Conditions
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Erosion of Teeth, Unspecified

Intervention / Treatment
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* Device: Candida Mouthwash with Curolox™ Peptide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candida Mouthwash with Curolox™ Peptide<br>Repeated applications 2.5 ml or 5 ml twice daily | Device: Candida Mouthwash with Curolox™ Peptide<br>* Prophylaxis - protection and care of teeth against caries & acidic challenges<br>* Other names: Candida Protect;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Immediately after rinsing with the mouthwash | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 hours, 24 hours, 48 hours, 96 hours |