Proof of Concept: Socket Seal

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03063775

Acronym

SocketSeal

Enrollment

Registered

2017-02-24

Start date

2017-01-09

Completion date

2018-11-08

Last updated

2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tissue Preservation

Brief 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.

Interventions

DEVICEBioOss® + Mucograft Seal®

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

OTHERFGG + Bio-Oss®

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

OTHERFGG + Gelatine sponge (Spongostan®)

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

DEVICESpongostan®+ Mucograft® Seal

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Soft tissue volume	2 weeks

Secondary

Measure	Time frame
Bone volume	3 months

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026