K02.0
Conditions
Interventions
Group 1: Curodont Repair (monomeric P11-4)
Group 2: Untreated control
Sponsors
Poliklinik für Zahnerhaltung, Parodontologie, Endodontologie, Präventive Zahnmedizin und Kinderzahnheilkunde im Zentrum für Zahn-, Mund- und Kieferheilkunde der Universitätsmedizin der Ernst-Moritz-Arndt Universität Greifswald
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: White spot (demineralisation) lesions present after removal of fixed orthodontic appliances • Size and form of the lesion: The lesion must be fully visible and assessable and accessible. • Able and willing to observe good oral hygiene throughout the study • = 20 teeth and a BP score of < 3 • Age = 12 years and = 65 years • Willing and able to attend the on-study visits • Willing and able to understand all study-related procedures • Written informed consent before participation in the study
Exclusion criteria
Exclusion criteria: Pre-treated carious lesion • Tooth with other carious lesions apart from the ones developed during orthodontic treatment • Patient suffers from diabetes • Evidence of tooth erosion (due to excessive acidic drink consumption) • History of head and neck illnesses (e.g. head & neck cancer) • Any pathology or concomitant medication affecting salivary flow • Any metabolic disorders affecting bone turnover • Concurrent participation in another clinical trial with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry • Any skin diseases • Patient being pregnant • Patient having a pacemaker
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Morphometric measurements of WSL with Shadepilot/TM (DeguDent / Germany) (day 0, day 45, day 90, and day 180) for the assessment of the change of the caries extent on the tooth surface. | — |
Primary
| Measure | Time frame |
|---|---|
| Impedance measurements of WSL with CarieScan Pro/TM (orangedental / Germany) (day 0, day 45, day 90, and day 180) for assessment of the caries progression/Regression. | — |
Countries
Germany
Contacts
Public ContactAlexander Welk
Poliklinik für Zahnerhaltung, Parodontologie, Endodontologie, Präventive Zahnmedizin und Kinderzahnheilkunde im Zentrum für Zahn-, Mund- und Kieferheilkunde der Universitätsmedizin der Greifswald
Outcome results
None listed