in situ studie to analzye the remineralizing efficacy of a new carbonate hydroxyapatite nanocrystals containnig toothpaste

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011653

Enrollment

Registered

2017-01-30

Start date

2017-04-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K02

Interventions

Group 1: The study design is a double-blinded, randomized, cross-over in situ trial with four treatment legs. After screening for general eligibility dental impressions of the lower jaw will be taken

Meyer-Lueckel et al., 2015c]. Furthermore, the acrylic resin (Orthocryl

Dentaurum, Pforzheim, Germany) of this side of the vestibular flanges will be transparent, indicating that only this flange has to be brushed. Specimens of the second flange will be inserted 1 mm belo

Hager & Werken, Duisburg, Germany) mimicking ‘plaque-retaining’ surfaces [Meyer-Lueckel et al., 2007

Meyer-Lueckel et al., 2015b

Schirrmeister et al., 2007]. Each specimen included one sound enamel/dentin area and one demineralized lesion. The factors under evaluation will be: •‘intervention’ at four levels: application of 1. f

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: •give written informed consent; •be between the ages of 18 and 70; •be in good general health; •agree not to participate in any other clinical study for the duration of this study; •agree to refrain from using any non-study oral hygiene products including: toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their usual toothbrush and toothpaste which will be used during the Acclimation period between each visit; •have a minimum of 20 teeth (excluding third molars); •agree to return for the scheduled clinical visits and follow study procedures;

Exclusion criteria

Exclusion criteria: •active participation in another oral/dental products clinical study; •current severe chronic illness or infectious disease; •drug or alcohol abuse; •eating disorders, •pregnancy or breast feeding; •antibiotic use (2 months before and during study) or medication reducing salivary flow; •intake of other medications that might have an impact on the outcome; •bad oral cleanliness, no agreement to comply with study design; •known allergic reactions to any of the test substances; •other allergic reactions to dental materials or oral hygiene products;

Design outcomes

Primary

Measure	Time frame
Before and after each experimental period the specimens are retrieved to assess lesion depth and mineral content by transversal microradiography (TMR).	—

Countries

Germany

Contacts

Public ContactRichard Wierichs

Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen

rwierichs@ukaachen.de0241 80-88110

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 19, 2026