Proof of Concept: Intra-oral Soft Tissue Preservation of Extraction Sockets in Anterior Upper Jaw
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tissue Preservation
- Sponsor
- Medical University of Graz
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Soft tissue volume
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Soft tissue volume
Time Frame: 8 weeks
Secondary Outcomes
- Bone volume(12 months)