NCT03797963

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2022

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

January 6, 2019

Last Update Submit

May 20, 2023

Conditions

Sinus Floor Augmentation

Keywords

Maxillary sinus augmentationSinus liftBiomaterialAnorganic bovine bonePorcine bone mineralImplant dentistry

Outcome Measures

Primary Outcomes (1)

  • Sinus floor height change

    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 Outcomes (5)

  • Sinus floor height change after 12 months

    From surgery to 12 months

  • Sinus floor height change after 18 months

    From surgery to 18 months

  • Area of new mineralized tissue

    6 months

  • Area of non-mineralized tissue

    6 months

  • Area of remaining graft particles

    6 months

Study Arms (2)

PBM+ACB

ACTIVE COMPARATOR

Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone

Device: PBM+ACB

ABB+ACB

EXPERIMENTAL

Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone

Device: ABB+ACB

Interventions

PBM+ACBDEVICE

Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone

PBM+ACB
ABB+ACBDEVICE

Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone

ABB+ACB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Granada

Granada, 18071, Spain

Location

Related Publications (3)

  • Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26.

    PMID: 29071736BACKGROUND

  • Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.

    PMID: 17355356BACKGROUND

  • Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3.

    PMID: 35224778RESULT

Study Officials

  • Pablo Galindo-Moreno, DDS, MS, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

January 6, 2019

First Posted

January 9, 2019

Study Start

January 8, 2019

Primary Completion

February 2, 2021

Study Completion

February 27, 2022

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

ES(1)