Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation

May 20, 2023 updated by: Pablo Galindo-Moreno, Universidad de Granada

Split-mouth Randomized Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation

The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using two different xenogenic biomaterials in combination with autogenous cortical bone for maxillary sinus floor elevation.

A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients will be assigned to receive a mix of autogenous cortical bone (collected by a bone scraper from the access window to the maxillary sinus) and anorganic bovine bone (BioOss Xenograft) in one maxillary sinus or autogenous cortical bone and porcine bone mineral (Symbios Xenograft) in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans will be performed before and after sinus floor elevation and 6, 12 and 18 months after the procedure to assess the bone gain. Bone core biopsies will be obtained at the site of implant placement 6 months after the floor elevation. Histological sections will be subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

  • Spain
      • Granada, Spain, 18071
        • Universidad de Granada

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Partially edentulous patients.
  • Kennedy class I in the upper jaw.
  • Less than 5 mm of residual crestal bone to the maxillary sinus.
  • Need for the replacement of teeth with dental implants.

Exclusion Criteria:

  • Sinus pathology (sinusitis, mucocele, cysts).
  • Smokers.
  • Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PBM+ACB
Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone
Device: PBM+ACB
Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone
Experimental: ABB+ACB
Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone
Device: ABB+ACB
Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinus floor height change
Time Frame: From surgery to 6 months
CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change
From surgery to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of new mineralized tissue
Time Frame: 6 months
Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
6 months
Area of non-mineralized tissue
Time Frame: 6 months
Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
6 months
Area of remaining graft particles
Time Frame: 6 months
Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure
6 months
Sinus floor height change after 12 months
Time Frame: From surgery to 12 months
CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change
From surgery to 12 months
Sinus floor height change after 18 months
Time Frame: From surgery to 18 months
CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change
From surgery to 18 months

Collaborators and Investigators

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

Sponsor

Universidad de Granada

Investigators

  • Principal Investigator: Pablo Galindo-Moreno, DDS, MS, PhD, Universidad de Granada

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)

January 8, 2019

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

February 27, 2022

Study Registration Dates

First Submitted

January 6, 2019

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 480CEIH2018

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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