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.
- Conditions
- Alveolar resorptionshrinking of the jaw10005944
- Registration Number
- NL-OMON42402
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
- 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
- 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
- Previous entry into this study or participation in any other clinical trial within 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Biopsy specimens from each patient at 5 months after sinus floor elevation<br /><br>surgery will be<br /><br>analyzed histomorphometrically on bone formation.<br /><br>• Implant survival is assessed at 5, 11, 17 and 23 months after sinus floor<br /><br>elevation surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pain and health related quality of life questionnaire at 7 time-points.</p><br>