K08.8 K08.2
Conditions
Sponsors
Purgo Biologics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with good oral hygienic status - Patients in need of bone augmentation of the alveolar bone - Patients who have bone defects in vertical and/or lateral dimension; vertical </= 4 mm or lateral </= 8 mm - No systemic diseases, which could influence the outcome of the therapy - Patients able to follow pre- and post-surgical instructions - Patient with informed consent
Exclusion criteria
Exclusion criteria: - Patients without severe systemic diseases - Patients with uncontrolled diabetes - Allergies to product components - Alcohol/ drug abuse - Patients not able to follow instructions - Patients w/o informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Radiographical (CBCT) Bone gain 3 months after ridge preservation procedure, evaluated via image analysis of radiological images compared to post-extraction 2. Histological & Histomorphometry (Biopsy) Bone quality, new bone formation, histomorphometrically evaluated in histological sections of biopsies gained during the implantation process | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain (VAS) – up to 7 days post-augmentation - Soft tissue healing up to 3 months after augmentation – evaluated via image analysis of clinical photo documentation - Implant success and stability – 3 months post-augmentation Implant survival – 3 months post-implantation - Occurrence of complications (e.g. infection, periimplantitis, implant loss) up to 6 months post surgery | — |
Countries
Germany
Outcome results
None listed