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About
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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
Two class V carious lesions which do not require an invasive treatment
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
Permanent dentition 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
Negative pregnancy test for women of childbearing potential
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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