Proof of Concept: Socket Seal

Tissue Preservation Clinical Trial

— SocketSeal  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03063775
• Other study ID #: 7333
• Status: Terminated
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: November 8, 2018

Study information

• Verified date: May 2019
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 8, 2018
• Est. primary completion date: November 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Tissue Preservation

Intervention

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.
• 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

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue volume		2 weeks
Primary	Soft tissue volume		4 weeks
Primary	Soft tissue volume		8 weeks
Secondary	Bone volume		3 months
Secondary	Bone volume		6 months
Secondary	Bone volume		12 months