Skip to main content
OpenTrials
Completed

NCT Number: NCT03474627

PLGA-coated Biphasic Calcium Phosphate in Sinus Lift

The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening properties.

A randomized clinical study is designed to include patients in need of two-stage sinus floor elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies are obtained at the site of implant placement. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sinus Floor Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada, Granada, Spain

Loading trial locations.

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 or II in the upper jaw, from first premolar to second molar.
  • Less than 5 mm of residual crestal bone.
  • 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

Non-coated HA/TCP particles

Device

Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft

PLGA-coated HA/TCP particles

Device

Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating

Primary outcomes

  1. Sinus floor height change

    Time frame: 6 months

    CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to measure vertical bone height from the crestal bone to the floor of the maxillary sinus.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Collaborators

  • University of Valencia

Registry information

Official study title

Sinus Floor Elevation Using Particulate and in Situ Hardening Biphasic Calcium Phosphate Bone Graft Substitutes: A Prospective Histological and Radiological Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Mar 22, 2018
Registry last updated
Mar 22, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.