Preventive effect of a CANDIDA toothpaste and mouth fluid containing the Curolox Peptide

Not Applicable

• Conditions: K02; K03; Dental caries; Other diseases of hard tissues of teeth

• Registration Number: DRKS00012248
• Lead Sponsor: Mibelle AG

Brief Summary

Aim: The protective effect of the peptide P11-4 on erosions should be examined in a randomized in-situ study. Subjects and methods: 24 subjects (6x male, 18x female, average age 37.0 years) were included in the study. A customized mandibular splint with human dental plaques on the buccal sides was fabricated for each participant. For each tooth plate, one half covered with plastic served as an internal control. The aligners were only removed to eat and brush your teeth. The cleaning/rinsing of the splints was carried out at defined times under supervision in the test center. The subjects were randomly assigned to three groups: A: test toothpaste (33 ppm P11-4 + 1450 ppm F-) and test mouthwash solution (7.5 ppm P11-4 + 220 ppm F-); B: test toothpaste (33ppm P11-4 + 1450ppm F-) and placebo rinse (220ppm F-); C: Placobo toothpaste (1450 ppm F-) and placebo rinse solution (220 ppm F-). After each cleaning/rinsing process, defined tooth plates were removed from the splint and stored in a 6% citric acid solution for 20 minutes. Using profilometry, the loss of enamel was determined on the sample surfaces compared to the internal control side. The difference between the two sides (?h) was measured for the samples from the following time points: S1: immediate effect after the first application; S2: effect after 2x cleaning and rinsing (8h after baseline); S3: Effect after 4x brushing and rinsing (32h after baseline/wearing the splint overnight). The groups were checked for significant differences (a=0.05) using ANOVA and post-hoc analyses. Results: The mean values ??for ?h were as follows: time point S1: A: 7.7 µm; B: 5.4 µm, C: 12.1 µm. Time S2: Group A: 6.3 µm; B: 5.9 µm; C: 8.0. Time S3: A 9.2; B: 7.5; C: 7.2. The differences between the groups were not statistically significant (p>0.05). Conclusion: Overall, a higher acid-protective effect after application of the P11-4 (A and B) compared to the placebo group (C) could be shown at different times. However, a cumulative effect of the P11-4 in toothpaste and rinsing solution was not confirmed.

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-10-15
• Study Start: 2017-04-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Age = 18 years and = 65 years
Willing and able to understand and to follow the study procedures and instructions
Willing to wear a dental appliance for 3 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

Study & Design

• Study Type: interventional
• Study Design: Not specified