Clinical evaluation of xenogene bone and soft tissue substitute materials in bone augmentation (Ridge Augmentation, lateral/vertical) of lower / upper jaw in preparation for implantation – a pilot study
- Conditions
- K08.8K08.2Other specified disorders of teeth and supporting structuresAtrophy of edentulous alveolar ridge
- Registration Number
- DRKS00031647
- Lead Sponsor
- Purgo Biologics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- All
- Target Recruitment
- 72
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 - No systemic diseases, which could influence the outcome of the therapy
- Patients able to follow pre- and post-surgical instructions
- Patient with informed consent
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Radiographical (CBCT)<br>Bone gain 3 months after ridge preservation procedure, evaluated via image analysis of radiological images compared to post-extraction <br> <br>2. Histological & Histomorphometry (Biopsy)<br>Bone quality, new bone formation, histomorphometrically evaluated in histological sections of biopsies gained during the implantation process
- Secondary Outcome Measures
Name Time Method - Pain (VAS) – up to 7 days post-augmentation<br>- Soft tissue healing up to 3 months after augmentation – evaluated via image analysis of clinical photo documentation <br>- Implant success and stability – 3 months post-augmentation<br>Implant survival – 3 months post-implantation <br>- Occurrence of complications (e.g. infection, periimplantitis, implant loss) up to 6 months post surgery
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