Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Semmelweis University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Duration of surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Bony wall group
In the bony wall group, following piezosurgery the retrieved bony wall was repositioned.
Intervention: Maxillary sinus augmentation (Procedure)
Collagen membrane group
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).
Intervention: Maxillary sinus augmentation (Procedure)
Outcomes
Primary Outcomes
Duration of surgery
Time Frame: During smaxillary sinus augmentation
Recorded in minutes
Secondary Outcomes
- Duration of lateral window preparation(During maxillary sinus augmentation)
- Duration of mucosa preparation(During maxillary sinus augmentation)
- Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)(1 day postoperatively)
- Postoperative Edema Score(3 days postoperatively)
- Histomorphometrical analysis(Following reentry 6 months after maxillary sinus augmentation)
- Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)(12 hours postoperatively)
- Postoperative Edema Score(2 days postoperatively)
Investigators
Balint Molnar
Dr. Balint Molnar DMD, PhD, associate professor
Semmelweis University