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

Mibelle

Status: Withdrawn

Conditions: Erosion of Teeth, Unspecified

Treatments: Device: Candida Mouthwash with Curolox™ Peptide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02308436

P11-4-MW15.042

Details and patient eligibility

About

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 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

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Candida Mouthwash with Curolox™ Peptide

Experimental group

Description:

Repeated applications 2.5 ml or 5 ml twice daily

Treatment:

Device: Candida Mouthwash with Curolox™ Peptide