NCT03063775

Proof of Concept: Socket Seal

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Tissue Preservation

Interventions

Type	Name	Description
DEVICE	BioOss® + Mucograft Seal®	Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket.
OTHER	FGG + Bio-Oss®	Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket.
OTHER	FGG + Gelatine sponge (Spongostan®)	Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket.
DEVICE	Spongostan®+ Mucograft® Seal	Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket

Timeline

• Start date: 2017-01-09
• Primary completion: 2018-11-08
• Completion: 2018-11-08
• First posted: 2017-02-24
• Last updated: 2019-05-15

Locations

1 site across 1 country: Austria