Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

Semmelweis University

Status and phase: Completed; Phase 4

Conditions: Maxillary Sinus Augmentation

Treatments: Procedure: Maxillary sinus augmentation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04811768

Sinus-Semmelweis-Perio

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Bony wall group

Experimental group

Description:

In the bony wall group, following piezosurgery the retrieved bony wall was repositioned.

Treatment:

Procedure: Maxillary sinus augmentation

Collagen membrane group

Experimental group

Description:

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).

Treatment:

Procedure: Maxillary sinus augmentation