An explorative clinical prospective feasibility study to address the effectiveness and safety ofcalciumphosphate/poly(lactic-co-glycolic-acid) for bone augmentation in maxillary sinus floorelevation surgery
Suspended
- Conditions
- Maxillary sinus floor elevation or sinusliftCalcium phosphate cement with poly(lactic-co-glycolic acid) or PLGAMaxillaire sinusbodemelevatie of sinusliftCalciumfosfaat cement met poly(lactic-co-glycolic acid) of PLGA
- Registration Number
- NL-OMON25916
- Lead Sponsor
- Radboudumc Tandheelkunde 309, BiomaterialenP.O. Box 91016500 HB Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 11
Inclusion Criteria
•Healthy male or female patients aged 18-70 years
•Patient is willing to give informed consent to participate in the study
Exclusion Criteria
•Maxillary sinus pathology
•Recent extractions in the involved area
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Assess the percentage of new bone formation by histological analysis and histomorphometry of biopsy specimens at 5 months after sinus floor elevation surgery.<br /><br>•Assess implant survival at 5 months and 14 days, 11 months, 17 months and 23 months after sinus floor elevation surgery.<br>
- Secondary Outcome Measures
Name Time Method •Assess the bone and/or augmented bone height by radiographic evaluation at intake and further at time points 0 (directly after sinus floor elevation surgery), 5 months (at implant placement) 11 months and 23 months of follow up.<br /><br>•Assess pain by using the Visual Analogue Scale (VAS-score) at all time points during follow-up.<br /><br>•Assess quality of life by using the SF-36 questionnaire at all time points during follow-up.<br /><br>•Assess adverse events during all follow-up visits.<br><br>