K08.1
Conditions
Sponsors
Purgo Biologics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with good hygienic oral conditions - Patients in need of extraction of one or more teeth; in case of more teeth the defect sites have to be in different quadrants - Patients with type 1 (intact alveolar) or type 2 sockets (compromised alveolar) - 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 with severe systemic disease - Patients with uncontrolled diabetes - Allergies to product components - Untreated caries - Alcohol/ drug abuse - Patients not able to follow instructions - Patients w/o informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone gain 3 months after ridge preservation procedure, evaluated via image analysis of radiological images compared to post-extraction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain (VAS) - 7 days post extraction 2. Soft tissue healing up to 3 months after ridge preservation, evaluated via semi-quantitative image analysis of clinical photo documentation 3. Bone quality via Implant success and stability at implantation surgery 3 months post-extraction 4. Implant survival after 3 years 5. Radiological evaluation of bone change at augmentation/implant site after 3 years, compared to post-extraction and pre-implantation situation 6. Occurrence of complications (e.g. infection, periimplantitis, implant loss) 7. Evaluation of safety measures via occurrence of (S)AE ((serious) adverse events), and medical device related events up to 3 months post-extraction | — |
Countries
Germany
Outcome results
None listed