K02.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age = 18 years low caries activity Willing and able to attend the on-study visits and assessments Willing and able to understand all study-related procedures and to follow the self-treatment instructions informed consent
Exclusion criteria
Exclusion criteria: Subjects with removable partial denture; Subjects with fixed orthodontic appliances; Subjects with current dental trauma or surgery; Last applied high-concentration fluoride treatment (elmexgelee, etc.) < 2 weeks; Smoker; Subjects with bronchial asthma; Evidence of tooth erosion; History of head and neck illnesses (e.g. head/neck cancer); Pregnant and breast-feeding women (no pregnancy test will be done for this clinical in situ study. Patient’s statement is considered as sufficient.); Any pathology or concomitant medication affecting salivary flow or dry mouth: unstimulated < 0.2 ml/min; Last taking of antibiotics < 2 months Patients receiving medication known to stain teeth like tetracycline or chlorhexidine high caries risk; Concurrent participation in another clinical trial; Subjects with known allergies//hypersensitivity towards agent of Curodont Protect or Duraphat varnish respectively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoint each arm: 4 weeks after wearing the appliance with specimen. Endpoint of the study: due to the crossover design 12 weeks. Measuring method: loss of mineral in enamel measured by micro-ct and fluoreszence. | — |
Secondary
| Measure | Time frame |
|---|---|
| Endpoint each arm: 4 weeks after wearing the appliance with specimen. Endpoint of the study: due to the crossover design 12 weeks. Measuring method: surface texture of specimen measured by scanning electron microscopy | — |
Countries
Germany
Contacts
Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kinderzahnheilkunde