K02.0
Conditions
Interventions
Group 1: Test group: Curodont Protect (P11-4), gel form, to be applied twice a week
Group 2: Control group: placebo gel (without P11-4), to be applied twice a week
Sponsors
Philipps-Universität Marburg, FB Medizin, MZ für ZMKAbt. für Kieferorthopädie
Eligibility
Sex/Gender
All
Age
11 Years to 18 Years
Inclusion criteria
Inclusion criteria: - Patients with a planned multibracket appliance (MB), - Written, signed declaration of consent from the patient and the legal guardian before the start of the study, - Individuals who are willing and able to attend all scheduled appointments, - Patients willing and able to understand all study-related procedures and follow home-care instructions.
Exclusion criteria
Exclusion criteria: - Individuals with removable dentures, - Individuals with recent dental trauma or dental surgery, - Patients with a current periodontal disease, - patients with bronchial asthma, - Signs of tooth erosion (excessive drinking of acidic drinks, reflux), - Medical conditions or concomitant medication that affect salivation or cause dry mouth, - Last antibiotic intake < 2 months, - Use of products that can cause tooth discoloration (e.g. chlorhexidine digluconate), - Patients with known allergies/hypersensitivity to the used materials, - Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of demineralizations (?F in %) in the defined period of 18 months after baseline, measured using quantitative light-induced fluorescence (QLF). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in (?F in %) over time: measurements every three months from baseline to study endpoint (18 months) | — |
Countries
Germany
Contacts
Public ContactAnahita Jablonski-Momeni
Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kieferorthopädie
Outcome results
None listed