NCT03474627

PLGA-coated Biphasic Calcium Phosphate in Sinus Lift

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sinus Floor Augmentation

Interventions

Type	Name	Description
DEVICE	Non-coated HA/TCP particles	Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft
DEVICE	PLGA-coated HA/TCP particles	Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-03-01
• Completion: 2017-03-01
• First posted: 2018-03-22
• Last updated: 2018-03-22

Locations

2 sites across 1 country: Spain