Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study

Conditions
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Maxillary Sinus Augmentation

Intervention / Treatment
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* Procedure: Maxillary sinus augmentation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bony wall group<br>In the bony wall group, following piezosurgery the retrieved bony wall was repositioned. | Procedure: Maxillary sinus augmentation<br>* The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.<br>* Other names: Sinus lift;|
| Experimental: Collagen membrane group<br>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). | Procedure: Maxillary sinus augmentation<br>* The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.<br>* Other names: Sinus lift;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | Recorded in minutes | During smaxillary sinus augmentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of lateral window preparation | Recorded in minutes | During maxillary sinus augmentation | 
| Duration of mucosa preparation | Recorded in minutes | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maxillary sinus, xenogeneic graft, collagen membrane, lateral bony wall repositioning, piezoelectric surgery