Proof of Concept: Socket Seal

Study Overview
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Brief Summary
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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.

Detailed Description
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In a proof of concept 5 groups are compared in preserving soft- and hard tissue after tooth extraction in the esthetic zone: Mucograft® Seal + Bio-Oss® Free Gingival Graft (FGG) + Bio-Oss® Free Gingival Graft + Gelatine sponge (Spongostan®) Spongostan®+ Mucograft® Seal Spongostan® Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.

Official Title
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Proof of Concept: Intra-oral Soft Tissue Preservation of Extraction Sockets in Anterior Upper Jaw

Conditions
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Tissue Preservation

Intervention / Treatment
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* Device: BioOss® + Mucograft Seal®
* Other: FGG + Bio-Oss®
* Other: FGG + Gelatine sponge (Spongostan®)
* Device: Spongostan®+ Mucograft® Seal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Planned extraction in the upper front or premolar region Exclusion Criteria: General risk situation (antiresorptive therapy, antiangiogenic therapy, history of local radiation therapy, heavy coagulation disorder, relevant allergies, dysregulated Diabetes mellitus, malignant diseases) Acute gingivitis Deep pockets (>5.5mm) Apical periodontitis on neighboring teeth Heavy smoker (>10/d)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Mucograft® Seal + Bio-Oss®<br> | Device: BioOss® + Mucograft Seal®<br>* Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket.<br>|
| Active Comparator: 2. FGG + Bio-Oss®<br> | Other: FGG + Bio-Oss®<br>* Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket.<br>|
| Active Comparator: 3. FGG + Gelatine sponge (Spongostan®)<br> | Other: FGG + Gelatine sponge (Spongostan®)<br>* Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket.<br>|
| Active Comparator: 4. Spongostan®+ Mucograft® Seal<br> | Device: Spongostan®+ Mucograft® Seal<br>* Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket<br>|
| No Intervention: 5. Spongostan®<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue volume |  | 2 weeks | 
| Soft tissue volume |  | 4 weeks | 
| Soft tissue volume |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone volume |  | 3 months | 
| Bone volume |  | 6 months | 
| Bone volume |  | 12 months |