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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

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

Interventions

  • Device: Candida Mouthwash with Curolox™ Peptide
    • Prophylaxis – protection and care of teeth against caries & acidic challenges

Arms, Groups and Cohorts

  • Experimental: Candida Mouthwash with Curolox™ Peptide
    • Repeated applications 2.5 ml or 5 ml twice daily

Clinical Trial Outcome Measures

Primary Measures

  • Detection of Curolox peptide by mass spectroscopy
    • Time Frame: 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 Measures

  • Detection of Curolox peptide by mass spectroscopy
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mibelle AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christian Besimo, Dr.med.dent., Principal Investigator, Aeskulap Klinik
    • Ulrich P. Saxer, Dr.med.dent., Study Director, Aeskulap Klinik / PZZN

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