K02.9
Conditions
Interventions
Group 1: Single local treatment of initial caries lesion with Curodont Repair on Day 0 and Day 90
Treatment time: ~5 Minutes.
Group 2: Single local treatment of initial caries lesions with Fluoride Varnish (Duraphat) on Day 0 and Day 90
Treatment time: 2 Minutes
Sponsors
credentis ag
Eligibility
Sex/Gender
All
Age
10 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Two buccal carious lesions which do not require operative intervention • Size and form of the lesions: the lesions must both be fully visible and assessable and accessible • Patients must be able and willing to observe good oral hygiene throughout the study • = 20 teeth and a plaque index of < 20% • Age = 10 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: • Secondary caries lesion on tooth • Enamel aberration • Carious lesions due to orthodontic treatment on tooth • Evidence of tooth erosion (due to excessive acidic drink consumption or reflux) • History of head and neck illnesses (e.g. head/neck cancer) • Any pathology or concomitant medication affecting salivary flow or dry mouth • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of the change in the lesion's size assessed by morphometry (on standardised photographs) from baseline D0 to D30 between investigational medical device and fluoride varnish. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference of the change in the lesion's size assessed by morphometry (on standardised photographs) from baseline D0 to D90, D180, D360 between investigational medical device and fluoride varnish. | — |
Countries
Germany
Contacts
Public ContactFrank Bröseler
Zahnärztliche Praxis für Parodontologie
Outcome results
None listed