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

Primary Purpose

Erosion of Teeth, Unspecified

Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Candida Mouthwash with Curolox™ Peptide
Sponsored by
Mibelle AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Erosion of Teeth, Unspecified

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aeskulap Klinik

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Candida Mouthwash with Curolox™ Peptide

Arm Description

Repeated applications 2.5 ml or 5 ml twice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2014
Last Updated
August 27, 2015
Sponsor
Mibelle AG
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1. Study Identification

Unique Protocol Identification Number
NCT02308436
Brief Title
Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide
Official Title
Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide: a Mono-centre, Not-controlled. Not Blinded, Not-randmised in Situ Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study is not realised.
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mibelle AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosion of Teeth, Unspecified

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Candida Mouthwash with Curolox™ Peptide
Arm Type
Experimental
Arm Description
Repeated applications 2.5 ml or 5 ml twice daily
Intervention Type
Device
Intervention Name(s)
Candida Mouthwash with Curolox™ Peptide
Other Intervention Name(s)
Candida Protect
Intervention Description
Prophylaxis - protection and care of teeth against caries & acidic challenges
Primary Outcome Measure Information:
Title
Detection of Curolox peptide by mass spectroscopy
Description
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
Secondary Outcome Measure Information:
Title
Detection of Curolox peptide by mass spectroscopy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Besimo, Dr.med.dent.
Organizational Affiliation
Aeskulap Klinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich P. Saxer, Dr.med.dent.
Organizational Affiliation
Aeskulap Klinik / PZZN
Official's Role
Study Director
Facility Information:
Facility Name
Aeskulap Klinik
City
Brunnen
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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