Comparison of Phicogenic vs. Xenogeneic Biomaterial for Maxillary Sinus Floor Elevation

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

Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.

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 a biphasic phicogenic biomaterial in comparison with anorganic bovine bone.

A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients are assigned to receive a mix of autogenous bone and a biphasic phycogenic biomaterial in one maxillary sinus and a mix of autogenous bone and xenograft bovine hydroxyapatite in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans are performed before sinus floor elevation and 6 months after the procedure to assess the bone gain. Bone core biopsies are obtained at the site of implant placement 6 months after the floor elevation. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

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
        • Facultad de Odontología

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: Biphasic phycogenic biomaterial
Biphasic phycogenic biomaterial and Autogenous cortical bone
Device: Biphasic phycogenic biomaterial
Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone
Experimental: Xenograft bovine hydroxyapatite
Xenograft bovine hydroxyapatite and Autogenous cortical bone
Device: Xenograft bovine hydroxyapatite
Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite 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 are performed before the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change from the crestal bone to the floor of the maxillary sinus
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

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, PhD, MS, 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)

September 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 24, 2018

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

  • 307CEIH2017

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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