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Sinus Floor AugmentationNCT03797963

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

A study testing PBM+ACB and ABB+ACB in people with Sinus Floor Augmentation, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sinus Floor Augmentation
What is being tested?
PBM+ACB and ABB+ACB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
8 Jan 2019to 27 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Granada

    Granada, 18071

Other trials in Spain

About this study

Official title: 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.

Being tested
PBM+ACB, ABB+ACB
Keywords
Maxillary sinus augmentation, Sinus lift, Biomaterial, Anorganic bovine bone, Porcine bone mineral, Implant dentistry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PBM+ACBDevice

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

  • ABB+ACBDevice

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

Study groups in NCT03797963
Study groupRoleWhat they receive
PBM+ACBActive comparatorPorcine bone mineral (Symbios Xenograft) + autogenous cortical bone
Receives: Device: PBM+ACB
ABB+ACBExperimentalAnorganic bovine bone (BioOss Xenograft) + autogenous cortical bone
Receives: Device: ABB+ACB

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From surgery to 6 months

Secondary outcomes (5)

  1. Sinus floor height change after 12 months

    CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change

    Measured: From surgery to 12 months

  2. Sinus floor height change after 18 months

    CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change

    Measured: From surgery to 18 months

  3. Area of new mineralized tissue

    Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure

    Measured: 6 months

  4. Area of non-mineralized tissue

    Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure

    Measured: 6 months

  5. Area of remaining graft particles

    Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2019
  2. Study start8 Jan 2019
  3. Primary completion2 Feb 2021
  4. Study completion27 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03797963
Sponsor's protocol ID
480CEIH2018
Status last verified
May 2023
First submitted
6 Jan 2019
Last updated
23 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29071736

  • 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.

    PubMed 17355356

  • 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.

    PubMed 35224778

Questions about this trial

What is this clinical trial studying?

A study testing PBM+ACB and ABB+ACB in people with Sinus Floor Augmentation, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sinus floor height change (time frame: From surgery to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03797963, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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