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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Semmelweis University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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