NL-OMON42402
Completed
Not Applicable
A clinical prospective feasibility study to address the effectiveness and safety of calciumphosphate/poly(lactic-co-glycolic-acid) for bone augmentation in maxillary sinus floor elevation surgery. - A clinical feasibility study on the effectivenes and safety of CPC-PLGA.
niversitair Medisch Centrum Sint Radboud0 sites11 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alveolar resorption
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 11
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Healthy male or female patients aged 18\-70 years
- •\- Patient qualifies for sinus floor elevation surgery
- •\- Presence of a maxillary, unilateral or bilateral, (partial) edentulous area involving the premolar and/or molar area
- •\- Presence of a residual alveolar ridge height between 3 and 6 mm
Exclusion Criteria
- •\- Maxillary sinus pathology
- •\- Recent extractions in the involved area
- •\- Presence of a local or systemic disease or treatment affecting bone formation
- •\- Contamination of the (area around the) operative field
- •\- Infectious diseases
- •\- Bone metabolic disease
- •\- Neurological disorders that could influence mental validity
- •\- Pregnant or breast\-feeding female patients
- •\- Patients undergoing cancer therapy including immune suppression, chemotherapy and radiation
- •\- Patients with a history of implant failure
Outcomes
Primary Outcomes
Not specified
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