Maxillary Sinus Augmentation
Conditions
Keywords
maxillary sinus, xenogeneic graft, collagen membrane, lateral bony wall repositioning, piezoelectric surgery
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.
Interventions
PROCEDUREMaxillary sinus augmentation
The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.
Sponsors
NSK Europe GmbH
Botiss Medical AG
Institut Straumann AG
Dicomlab Kft.
Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006)
Excellence Program of the Ministry for Innovation and Technology in Hungary
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Histology analysis was performed blinded, randomization sequence was revealed after histomorphometry
Intervention model description
40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of surgery | During smaxillary sinus augmentation | Recorded in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 12 hours postoperatively | Measurement of patient discomfort |
| Postoperative Edema Score | 2 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 |
Countries
Hungary
Outcome results
None listed