Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

Semmelweis University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Maxillary Sinus Augmentation

Interventions

Maxillary sinus augmentationPROCEDURE

The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Semmelweis University Department of Periodontology

Budapest, Hungary

Outcomes

Primary Outcomes

Duration of surgery

Recorded in minutes

Time frame: During smaxillary sinus augmentation

Secondary Outcomes

Duration of lateral window preparation

Recorded in minutes

Time frame: During maxillary sinus augmentation

Duration of mucosa preparation

Recorded in minutes

Time frame: During maxillary sinus augmentation

Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)

Measurement of patient discomfort

Time frame: 12 hours postoperatively

Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)

Measurement of patient discomfort

Time frame: 1 day postoperatively

Postoperative Edema Score

Measurement of swelling

Time frame: 2 days postoperatively

Postoperative Edema Score

Measurement of swelling

Time frame: 3 days postoperatively

Histomorphometrical analysis

Percentage of newly formed bone, bone substitute and connective tissue

Time frame: Following reentry 6 months after maxillary sinus augmentation

Data from ClinicalTrials.gov

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