Clinical trial NCT04811768: Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation
Official title: Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Maxillary Sinus Augmentation
Keywords: maxillary sinus
xenogeneic graft
collagen membrane
lateral bony wall repositioning
piezoelectric surgery
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: NSK Europe GmbH
name: Botiss Medical AG
name: Institut Straumann AG
name: Dicomlab Kft.
name: Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006)
name: Excellence Program of the Ministry for Innovation and Technology in Hungary
First posted: 2021-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of surgery
timeFrame: During smaxillary sinus augmentation
Secondary outcomes:
measure: Duration of lateral window preparation
timeFrame: During maxillary sinus augmentation
measure: Duration of mucosa preparation
timeFrame: During maxillary sinus augmentation
measure: Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)
timeFrame: 12 hours postoperatively
measure: Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)
timeFrame: 1 day postoperatively
measure: Postoperative Edema Score
timeFrame: 2 days postoperatively
measure: Postoperative Edema Score
timeFrame: 3 days postoperatively
measure: Histomorphometrical analysis
timeFrame: Following reentry 6 months after maxillary sinus augmentation
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Periodontology
Study officials:
References:
citation: Molnar B, Jung AK, Papp Z, Martin A, Orban K, Prohl A, Jung O, Barbeck M, Windisch P. Comparative analysis of lateral maxillary sinus augmentation with a xenogeneic bone substitute material in combination with piezosurgical preparation and bony wall repositioning or rotary instrumentation and membrane coverage: a prospective randomized clinical and histological study. Clin Oral Investig. 2022 Aug;26(8):5261-5272. doi: 10.1007/s00784-022-04494-x. Epub 2022 May 20.