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Completed

NCT Number: NCT03797963

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.

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Key information

Conditions

Sinus Floor Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Granada

Granada, 18071, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PBM+ACB

Device

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

ABB+ACB

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 9, 2019
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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