Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

March 19, 2021 updated by: Balint Molnar, Semmelweis University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bony wall group
In the bony wall group, following piezosurgery the retrieved bony wall was repositioned.
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.
Other Names:
  • Sinus lift
Experimental: Collagen membrane group
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
The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.
Other Names:
  • Sinus lift

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sinus-Semmelweis-Perio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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