Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation
- Conditions
- Maxillary Sinus Augmentation
- Interventions
- Procedure: Maxillary sinus augmentation
- Registration Number
- NCT04811768
- Lead Sponsor
- Semmelweis University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- at least one missing maxillary premolar or molar
- at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)
- maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)
- full mouth plaque and bleeding scores (FMPS and FMBS) <20%
- satisfactory patient compliance (e.g. to participate in follow-up procedures)
- signed informed consent.
- clinically relevant diseases (e.g.: diabetes, rheumatism cancer)
- untreated periodontitis
- systemic steroid use
- bisphosphonate use
- acute or chronic inflammatory processes
- previous endoscopic sinus surgery
- previous sinus floor elevation
- GBR-treatment at the study site
- GTR-treatment at the study site
- tooth removal within 6 weeks prior to surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bony wall group Maxillary sinus augmentation In the bony wall group, following piezosurgery the retrieved bony wall was repositioned. Collagen membrane group Maxillary sinus augmentation In the collagen membrane group, the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany).
- Primary Outcome Measures
Name Time Method Duration of surgery During smaxillary sinus augmentation Recorded in minutes
- Secondary Outcome Measures
Name Time Method Duration of lateral window preparation During maxillary sinus augmentation Recorded in minutes
Duration of mucosa preparation During maxillary sinus augmentation Recorded in minutes
Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse) 1 day postoperatively Measurement of patient discomfort
Postoperative Edema Score 3 days postoperatively Measurement of swelling
Histomorphometrical analysis Following reentry 6 months after maxillary sinus augmentation Percentage of newly formed bone, bone substitute and connective tissue
Trial Locations
- Locations (1)
Semmelweis University Department of Periodontology
ðŸ‡ðŸ‡ºBudapest, Hungary