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The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to no treatment.
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 the other will not undergo a treatment as control. Study duration is 12 months. For assessment x-ray pictures are used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curodont Repair | Experimental | Single application on Day 0. |
|
| No treatment - control | Other | No treatment as control - "wait and see". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curodont Repair | Device | Single application on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 360 |
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Inclusion Criteria:
D1 (outer half of enamel) D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Heimlinger, Dr. med. dent. | zumstein dental clinic ag | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zumstein Dental Clinic Ag | Lucerne | Canton of Lucerne | 6003 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23969679 | Background | Brunton PA, Davies RP, Burke JL, Smith A, Aggeli A, Brookes SJ, Kirkham J. Treatment of early caries lesions using biomimetic self-assembling peptides--a clinical safety trial. Br Dent J. 2013 Aug;215(4):E6. doi: 10.1038/sj.bdj.2013.741. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| No treatment - control | Other |
|