The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early buccal carious lesions compared to placebo.
All study participants must have two early class V 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 placebo as control (single application). 3 months later fluoride (Duraphat) will be applied on both lesions. Study duration is 9 months. For assessment visual and tactile evaluation, pictures, ECM, Diagnodent Pen, Canary System, VAS is used.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Self-assembling peptide, biomimetic re-mineralisation
Formulation of Curodont Repair without the peptide P11-4
Single application on day D90
University of Geneva - Devision of Cariology and Endodontology
Geneva, Switzerland
The primary efficacy outcome is the difference of the change in the lesion size assessed by morphometry (standardised pictures) between investigational medical device and placebo group.
Change of lesion size relative to baseline between study groups and different time points
Time frame: D0, D30, D90, D270
Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.
only descriptively analysed
Time frame: D0, D30, D90, D180, D270
Change in lesion's progression assessed by VAS between investigational medical device and placebo group.
only descriptively analysed
Time frame: D0, D30, D90, D180, D270
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