Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

Maxillary Sinus Augmentation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811768
• Other study ID #: Sinus-Semmelweis-Perio
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: March 2021
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Maxillary Sinus Augmentation

Intervention

Procedure:
• Maxillary sinus augmentation
The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.

Locations

Country	Name	City	State
Hungary	Semmelweis University Department of Periodontology	Budapest

Sponsors (7)

Lead Sponsor	Collaborator
Semmelweis University	Botiss Medical AG, Dicomlab Kft., Excellence Program of the Ministry for Innovation and Technology in Hungary, Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006), Institut Straumann AG, NSK Europe GmbH

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of surgery	Recorded in minutes	During smaxillary sinus augmentation
Secondary	Duration of lateral window preparation	Recorded in minutes	During maxillary sinus augmentation
Secondary	Duration of mucosa preparation	Recorded in minutes	During maxillary sinus augmentation
Secondary	Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)	Measurement of patient discomfort	12 hours postoperatively
Secondary	Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)	Measurement of patient discomfort	1 day postoperatively
Secondary	Postoperative Edema Score	Measurement of swelling	2 days postoperatively
Secondary	Postoperative Edema Score	Measurement of swelling	3 days postoperatively
Secondary	Histomorphometrical analysis	Percentage of newly formed bone, bone substitute and connective tissue	Following reentry 6 months after maxillary sinus augmentation