Proof of Concept: Socket Seal (SocketSeal)

Medical University of Graz

Status: Terminated

Conditions: Tissue Preservation

Treatments: Other: FGG + Gelatine sponge (Spongostan®); Other: FGG + Bio-Oss®; Device: BioOss® + Mucograft Seal®; Device: Spongostan®+ Mucograft® Seal

Study type: Interventional

Funder types: Other

Identifiers

NCT03063775

7333

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 5 patient groups

1. Mucograft® Seal + Bio-Oss®

Active Comparator group

Treatment:

Device: BioOss® + Mucograft Seal®

2. FGG + Bio-Oss®

Active Comparator group

Treatment:

Other: FGG + Bio-Oss®

3. FGG + Gelatine sponge (Spongostan®)

Active Comparator group

Treatment:

Other: FGG + Gelatine sponge (Spongostan®)

4. Spongostan®+ Mucograft® Seal

Active Comparator group

Treatment:

Device: Spongostan®+ Mucograft® Seal

5. Spongostan®

No Intervention group