Proof of Concept: Socket Seal
- Conditions
- Tissue Preservation
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
• Planned extraction in the upper front or premolar region
- 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
- 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
Medical University Graz🇦🇹Graz, Styria, Austria