Mond- en kaakchirurgie atrophic posterior maxilla reduced bone height of the sinus floor
Conditions
Interventions
Patients will undergo sinus floor augmentation with Micro-structured BCP
granules as bone graft substitute. A biopsy will be obtained from the maxilla
before implant placement.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male or female patients aged 18-70 years * Presence of a unilateral or bilateral partial maxillary edentulism involving the premolar/molar areas * Presence of a residual posterior maxillary bone height between 2 and 6 mm * Patient qualifies for sinus augmentation surgery
Exclusion criteria
Exclusion criteria: * Maxillary sinus pathology * Presence of a local or systemic disease or treatment affecting bone formation * Contamination of the (area around the) operative field * Periodontitis * Infectious diseases * Bone metabolic disease * Psychologic instability * Neurological disorders that could influence mental validity * Smoking * Female of child bearing potential, who are pregnant or breast-feeding * Cancer therapy including immune-suppression, chemotherapy and radiation * Patients in which primary stability could not be established * Previous entry into this study or participation in any other clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage of new bone formation in the augmented sinus floor by histomorphometrical analysis of biopsy specimens at 5 months of follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Implant survival rate and adverse events during 17 months of follow up. - Augmented bone height, volume and bone-implant-contact area (only at 11 and 17 months) in relation to the endosseous dental implant as measured by CBCT at 5, 11 and 17 months of follow up. - Implant stability quotient (ISQ) as measured by resonance frequency analysis (RFA) at 5 months (after implant placement) and 11 months of follow-up. - Scoring of gingival index, supra-gingival plaque index, and dichotomous bleeding index 17 months after surgery. - Probing depth of implant and adjacent teeth (buccodistal, buccomedial, buccomesial) at 17 months after surgery. - Pain by the Visual Analogue Scale (VAS-score) at visit 2 to 6. | — |
Countries
Netherlands
Outcome results
None listed