The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to fluoride.
All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and one with fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360
Application on Day 0, Day 180, Day 360, Day 540
Zahnheilkunde Seifert Gmbh
Sirnach, Thurgau, Switzerland
Opaqueness on X-Ray
The primary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 0 to Day 365 between test and control group.
Time frame: Day 360
Additional benefit of a second Curodont Repair application
The secondary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 360 to Day 720 between test and control group.
Time frame: Day 720
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