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| ID | Type | Description | Link |
|---|---|---|---|
| 14934.1 PFLS-LS | Other Grant/Funding Number | Swiss Committee for Technology and Innovation KTI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curodont Repair | Experimental | Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90. |
|
| Placebo | Placebo Comparator | Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curodont Repair | Device | Self-assembling peptide, biomimetic re-mineralisation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | D0, D30, D90, D270 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the change of Diagnodent Pen values between investigational medical device and placebo group. | only descriptively analysed | D0, D30, D90, D180, D270 |
| Change in lesion's progression assessed by VAS between investigational medical device and placebo group. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Ivo Krejci, Prof. Dr. | University of Geneva, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Geneva - Devision of Cariology and Endodontology | Geneva | 1205 | Switzerland |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Placebo | Other | Formulation of Curodont Repair without the peptide P11-4 |
|
| Fluoride | Device | Single application on day D90 |
|
only descriptively analysed |
| D0, D30, D90, D180, D270 |