Semmelweis University Department of Periodontology
Budapest, 1088, Hungary
NCT Number: NCT04811768
The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Budapest, 1088, Hungary
40 patients were randomly divided in two study groups after radiological and clinical evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM, cerabone, botiss biomaterials GmbH, Zossen, Germany) using the lateral approach. In the bony wall group (BW), following piezosurgery the retrieved bony wall was repositioned. In the collagen membrane group (CM), the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). After 6 months, biopsies were taken to analyze both approaches in terms of new bone formation. Duration of treatment, the number of perforations, postoperative patient discomfort were registered. Established histopathological analysis and histomorphometrical measurements to analyze the tissue reactions and the tissue distribution, i.e., the fractions of newly formed bone tissue (NB), of remaining bone substitute material (BSM) and connective tissue (CT), were conducted.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.
Other names: Sinus lift
Time frame: During smaxillary sinus augmentation
Recorded in minutes
Time frame: During maxillary sinus augmentation
Recorded in minutes
Time frame: During maxillary sinus augmentation
Recorded in minutes
Time frame: 12 hours postoperatively
Measurement of patient discomfort
Time frame: 1 day postoperatively
Measurement of patient discomfort
Time frame: 2 days postoperatively
Measurement of swelling
Time frame: 3 days postoperatively
Measurement of swelling
Time frame: Following reentry 6 months after maxillary sinus augmentation
Percentage of newly formed bone, bone substitute and connective tissue
Semmelweis University
Other
Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study
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