Sinus floor augmentation with microstructured BCP granules
Recruiting
- Conditions
- Maxillary sinus floor augmentation, sinus pneumatization, maxillary atrophy, maxillaire sinusbodem elevatie, maxillaire atrophy, sinus penumatisatie
- Registration Number
- NL-OMON29673
- Lead Sponsor
- niversity Medical Center Utrecht, Department of Oral and Maxillofacial Surgery & Special Dentistry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Male or female patients aged 18-75 years
- Patient is willing to give informed consent to participate in the study
Exclusion Criteria
- Maxillary sinus pathology
- Presence of a local or systemic disease or treatment affecting bone formation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of new bone formation in the augmented sinus floor by histomorphometrical analysis of biopsy specimens at 5 months of follow up.
- Secondary Outcome Measures
Name Time Method - Implant survival rate and adverse events during 17 months of follow up.<br /><br>- Augmented bone height as measured by CBCT at 5, 11 and 17 months of follow up.<br /><br>- Implant stability quotient (ISQ) as measured by resonance frequency analysis (RFA) at 5 months (primary stability) and 11 months of follow-up.<br /><br>- Scoring of gingival index, supra-gingival plaque index, and dichotomous bleeding index 17 months after surgery.<br /><br>- Probing depth of implant and adjacent teeth (buccal, palatinal, distal, mesial) at 17 months after surgery. <br /><br>- Pain by the Visual Analogue Scale (VAS-score)<br>