Not provided
Not provided
Not provided
Not provided
Lack of suitable patients for recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If so, this would provide a substantial benefit to the patient as the second intervention on the palate and the subsequent morbidity of the donor site is omitted.
In a proof of concept 5 groups are compared in preserving soft- and hard tissue after tooth extraction in the esthetic zone:
Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Mucograft® Seal + Bio-Oss® | Active Comparator |
| |
| 2. FGG + Bio-Oss® | Active Comparator |
| |
| 3. FGG + Gelatine sponge (Spongostan®) | Active Comparator |
| |
| 4. Spongostan®+ Mucograft® Seal | Active Comparator |
| |
| 5. Spongostan® | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioOss® + Mucograft Seal® | Device | Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue volume | 2 weeks | |
| Soft tissue volume | 4 weeks | |
| Soft tissue volume | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bone volume | 3 months | |
| Bone volume | 6 months | |
| Bone volume |
Not provided
Inclusion Criteria:
• Planned extraction in the upper front or premolar region
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | Styria | 8010 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C027539 | fibrinopeptides gamma |
| C077540 | Bio-Oss |
| D005339 | Fibrin Foam |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FGG + Bio-Oss® | Other | Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket. |
|
| FGG + Gelatine sponge (Spongostan®) | Other | Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket. |
|
| Spongostan®+ Mucograft® Seal | Device | Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket |
|
| 12 months |