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

NCT02308436 | Withdrawn

• 1 other identifier: P11-4-MW15.042
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Erosion of Teeth, Unspecified

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Detection of Curolox peptide by mass spectroscopy

  12 hours, 24 hours, 48 hours, 96 hours

Study Arms (1)

Candida Mouthwash with Curolox™ Peptide

EXPERIMENTAL

Repeated applications 2.5 ml or 5 ml twice daily

Device: Candida Mouthwash with Curolox™ Peptide

Interventions

Candida Mouthwash with Curolox™ Peptide DEVICE

Prophylaxis - protection and care of teeth against caries \& acidic challenges

Also known as: Candida Protect

Candida Mouthwash with Curolox™ Peptide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mibelle AG: lead

Study Sites (1)

Aeskulap Klinik

Brunnen, Switzerland

Location

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Study Officials

• Christian Besimo, Dr.med.dent.

  Aeskulap Klinik

  PRINCIPAL INVESTIGATOR

• Ulrich P. Saxer, Dr.med.dent.

  Aeskulap Klinik / PZZN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 4, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

CH (1)