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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Erosion of Teeth, Unspecified
• Intervention / Treatment: Device: Candida Mouthwash with Curolox™ Peptide

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Brunnen, Switzerland
    • Aeskulap Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Candida Mouthwash with Curolox™ Peptide; 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; Other Names: Candida Protect

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mibelle AG
• Investigators: Principal Investigator: Christian Besimo, Dr.med.dent., Aeskulap Klinik; Study Director: Ulrich P. Saxer, Dr.med.dent., Aeskulap Klinik / PZZN

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: November 27, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Estimate): August 28, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Tooth Erosion
• Other Study ID Numbers: P11-4-MW15.042