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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00003586 | Registry Identifier | Deutsches Register Klinischer Studien | |
| CIV-11-12-003323 | Other Identifier | EUDAMED |
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The objective of this study is to investigate the safety and the function of the collagen Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and III.
Study patients must have a single tooth gap with insufficient soft tissue volume after implant placement. Therefore a soft tissue augmentation will be necessary.
The primary objective of this study is to assess the effectiveness of soft tissue volume augmentation procedures using the autogenous soft tissue graft or the Collagen Matrix 10808 to gain mucosal thickness. Second the safety of the two procedures will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen Matrix 10808 | Experimental | Mucosal split-thickness flap in combination with the Collagen Matrix 10808. |
|
| Connective tissue graft (gold standard) | Other | Mucosal split-thickness flap in combination with the connective tissue graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Matrix 10808 | Device | At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Collagen Matrix 10808 will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound. |
| Measure | Description | Time Frame |
|---|---|---|
| Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing | at day 90 compared to day 0 (Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Adverse Events | from Day 0 to Day 90 | |
| Closure of the wound | at Day 7, 30, 90 | |
| Presence of Swelling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenz Uebersax, PhD | Geistlich Pharma AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich | Zurich | 8032 | Switzerland |
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| ID | Type | URL | Comment |
|---|---|---|---|
| PMID: 27310522 | 1. Publication | View IPD |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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|
| Connective tissue graft | Procedure | At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Connective tissue graft (Gold Standard) will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound. |
|
| at Day 7, 30, 90 |
| Oral health impact profile (OHIP-G14) score | at day 0, 7, 90 |
| Daily Mefenaminacid consumption | between Day 0 and Day 7 |
| Evaluation of pain using a VAS(Visual Analogue Scale) score daily | between Day 0 and day 7 and at Day 30 and 90 |
| Surgery time | at surgery |
| Qualitative histological assessment regarding matrix degradation and safety parameters | at day 90 |
| Gain in mucosal soft tissue thickness by 3D volumetric analysis | at day 90, compared to day 0 |
| Gain in mucosal soft tissue thickness measured by trans-mucosal probing | at day 30 compared to day 0 |
| Keratinized Tissue width (mm) | at day 0 and at day 90 |
| Probing Depth (mm) | at day 0 and at day 90 |
| Clinical Attachment Level (mm) | at day 0 and at day 90 |
| Bleeding of Probing (0/1) | at day 0 and at day 90 |
| Plaque Index (0-3) | at day 0 and at day 90 |
| Recession depth (mm) | at day 0 and at day 90 |
A first publication was published concerning the primary outcome of the transmucosal measurements. |
| PMID: 28107560 | 2. publicaton | View IPD | 2. publication concerning the volumetric changes of the soft tissue |