Proof of Concept: Socket Seal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2018-11-08

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.

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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:

1. Mucograft® Seal + Bio-Oss®
2. Free Gingival Graft (FGG) + Bio-Oss®
3. Free Gingival Graft + Gelatine sponge (Spongostan®)
4. Spongostan®+ Mucograft® Seal
5. Spongostan®

Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.

Conditions

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Tissue Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Mucograft® Seal + Bio-Oss®

Group Type ACTIVE_COMPARATOR

BioOss® + Mucograft Seal®

Intervention Type DEVICE

Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket.

2. FGG + Bio-Oss®

Group Type ACTIVE_COMPARATOR

FGG + Bio-Oss®

Intervention Type OTHER

Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket.

3. FGG + Gelatine sponge (Spongostan®)

Group Type ACTIVE_COMPARATOR

FGG + Gelatine sponge (Spongostan®)

Intervention Type OTHER

Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket.

4. Spongostan®+ Mucograft® Seal

Group Type ACTIVE_COMPARATOR

Spongostan®+ Mucograft® Seal

Intervention Type DEVICE

Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket

5. Spongostan®

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BioOss® + Mucograft Seal®

Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket.

Intervention Type DEVICE

FGG + Bio-Oss®

Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket.

Intervention Type OTHER

FGG + Gelatine sponge (Spongostan®)

Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket.

Intervention Type OTHER

Spongostan®+ Mucograft® Seal

Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No