The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions
Iuliu Hatieganu, University of Medicine and Pharmacy
Cluj-Napoca, Romania
White Spot Measurement
Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.
Time frame: Baseline to 1 Year
ICDAS II Visual Scoring System (Codes)
Evaluation of the clinical status of the lesions: 0: Sound tooth surface: No evidence of caries after 5 sec air drying 1. First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry 3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying 4. Underlying dark shadow from dentin 5. Distinct cavity with visible dentin 6. Extensive (more than half the surface) distinct cavity with visible dentin
Time frame: Baseline to 1 Year
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