ong-term clinical outcome after reconstruction of atrophied alveolar ridge using collagenated xenogeneic bone block (CXBB) or autogenous bone block (ABB). Follow-up of randomized controlled clinical investigation 10828-021.
- Conditions
- Survival of the implants as well as the bone tissue and soft tissue at the augmented area
- Registration Number
- DRKS00017137
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
Successful atrophied alveolar ridge reconstruction in clinical investigation 10828-021
- Implant placement at restored site
- Implant loading
- Written informed consent
- Final impression taken at the delivery of the implant-supported restoration (Visit 10 in study No. 10828-021) (Amendment No.1)
Exclusion Criteria
- Newly diagnosed diseases interfering with bone metabolism
- Severe trauma to implant site
- Orthodontic treatment in the same quadrant
- Participation in a clinical study interfering with the objective of this non-interventional long-term follow-up observation
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Assessment of implant presence in the mouth at 1, 2, 3, 4, and 5 years after implant placement (V6) in clinical investigation 10828-021.
- Secondary Outcome Measures
Name Time Method - Peri-implant clinical parameters will be determined by a periodontal probe at 1, 2, 3, 4, and 5 years after implant placement (V6) in clinical investigation 10828-021<br>- Marginal Bone Resorption will be measured <br>- Tissue volumetric changes will be evaluated <br>- Surgeon’s esthetic assessment <br>- Subject’s questionnaire on Oral Health-Related Quality of Life<br>- Assessment of subject’s outcome satisfaction (VAS)<br>- Implant success evaluation