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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