Proof of Concept: Socket Seal

Not Applicable

Terminated

• Conditions: Tissue Preservation
• Interventions: Device: BioOss® + Mucograft Seal®; Other: FGG + Bio-Oss®; Other: FGG + Gelatine sponge (Spongostan®); Device: Spongostan®+ Mucograft® Seal

• Registration Number: NCT03063775
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2017-01-09
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Primary Completion: 2018-11-08
• Study Completion: 2018-11-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Mucograft® Seal + Bio-Oss®	BioOss® + Mucograft Seal®	-
2. FGG + Bio-Oss®	FGG + Bio-Oss®	-
3. FGG + Gelatine sponge (Spongostan®)	FGG + Gelatine sponge (Spongostan®)	-
4. Spongostan®+ Mucograft® Seal	Spongostan®+ Mucograft® Seal	-

Primary Outcome Measures

Name	Time	Method
Soft tissue volume	8 weeks

Secondary Outcome Measures

Name	Time	Method
Bone volume	12 months

Trial Locations

Locations (1)

Medical University Graz; 🇦🇹 Graz, Styria, Austria