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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curodont Repair | Experimental | Application on Day 0 and Day 360 |
|
| Fluoride | Active Comparator | Application on Day 0, Day 180, Day 360, Day 540 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curodont Repair | Device | Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 720 |
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Inclusion Criteria:
Two approximal carious lesions on different teeth with at least one tooth in between
Both study lesions must not require an invasive treatment
Size and form of the lesions: the lesions must be fully visible and assessable on radiographs
The two carious lesions must fall into classes:
Able and willing to observe good oral hygiene throughout the study
Age ≥ 18 years 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathias Seifert, Med. dent. | Zahnheilkunde Seifert Gmbh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zahnheilkunde Seifert Gmbh | Sirnach | Thurgau | 8370 | 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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| Fluoride | Device | Application on Day 0, Day 180, Day 360, Day 540 |
|
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