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The clinical trial studies patients with gingival recession defects (receding gums).
The goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. The comparison group comprises patients receiving treatment with CAF and CM without the use of EMD.
The study aims to evaluate the influence of the additional use of EMD in treatment of gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by means of digital and clinical assessment methods. The reference group comprises patients receiving treatment with CAF and CM without the application of EMD.
In this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year.
15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I or II) were recruited and were randomly assigned into the two treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAF + CM | Active Comparator | Coronally advanced flap (CAF) and collagen matrix (CM) |
|
| CAF + CM +EMD | Experimental | Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of coronally advanced flap (CAF) and collagen matrix (CM) | Device |
| ||
| Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD). |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival recession height | Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin | 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Width of keratinized tissue (WKT) | Width of keratinized tissue in millimeters, .as distance between gingival margin and muco-gingival junction | 12 months postoperatively |
| pocket probing depth (PPD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Device |
|
Pocket probing depth in millimeters, measured as the distance from gingival margin to bottom of gingival sulcus
| 12 months postoperatively |
| Clinical attachment loss (CAL) | Clinical attachment loss in millimeters | 12 months postoperatively |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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