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

Not Applicable

Withdrawn

• Conditions: Erosion of Teeth, Unspecified
• Interventions: Device: Candida Mouthwash with Curolox™ Peptide

• Registration Number: NCT02308436
• Lead Sponsor: Mibelle AG

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

Study Timeline

• Study First Submitted: 2014-11-27
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Study Start: 2015-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-27
• Last Update Posted: 2015-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Candida Mouthwash with Curolox™ Peptide	Candida Mouthwash with Curolox™ Peptide	Repeated applications 2.5 ml or 5 ml twice daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aeskulap Klinik; 🇨🇭 Brunnen, Switzerland