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| Name | Class |
|---|---|
| NSK Europe GmbH | INDUSTRY |
| Botiss Medical AG | OTHER |
| Institut Straumann AG | INDUSTRY |
| Dicomlab Kft. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bony wall group | Experimental | In the bony wall group, following piezosurgery the retrieved bony wall was repositioned. |
|
| Collagen membrane group | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxillary sinus augmentation | Procedure | The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of surgery | Recorded in minutes | During smaxillary sinus augmentation |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of lateral window preparation | Recorded in minutes | During maxillary sinus augmentation |
| Duration of mucosa preparation | Recorded in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Department of Periodontology | Budapest | 1088 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35593928 | Derived | 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. |
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| ID | Term |
|---|---|
| D059546 | Sinus Floor Augmentation |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016025 | Bone Transplantation |
| D019637 | Orthopedic Procedures |
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| UNKNOWN |
| Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006) | UNKNOWN |
| Excellence Program of the Ministry for Innovation and Technology in Hungary | UNKNOWN |
40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage
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Histology analysis was performed blinded, randomization sequence was revealed after histomorphometry
|
| During maxillary sinus augmentation |
| Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse) | Measurement of patient discomfort | 12 hours postoperatively |
| Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse) | Measurement of patient discomfort | 1 day postoperatively |
| Postoperative Edema Score | Measurement of swelling | 2 days postoperatively |
| Postoperative Edema Score | Measurement of swelling | 3 days postoperatively |
| Histomorphometrical analysis | Percentage of newly formed bone, bone substitute and connective tissue | Following reentry 6 months after maxillary sinus augmentation |
| D003813 | Dentistry |