PLGA-coated Biphasic Calcium Phosphate in Sinus Lift

Not Applicable

Completed

• Conditions: Sinus Floor Augmentation
• Interventions: Device: Non-coated HA/TCP particles; Device: PLGA-coated HA/TCP particles

• Registration Number: NCT03474627
• Lead Sponsor: Universidad de Granada

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-03
• Study Completion: 2017-03
• Status Verified: 2018-03
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-15
• Last Update Submitted: 2018-03-15
• Study First Posted: 2018-03-22
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-coated HA/TCP particles	Non-coated HA/TCP particles	Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft
PLGA-coated HA/TCP particles	PLGA-coated HA/TCP particles	Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating

Primary Outcome Measures

Name	Time	Method
Sinus floor height change	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 Outcome Measures

Name	Time	Method
Area of new mineralized tissue	6 months	Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Area of non-mineralized tissue	6 months	Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Area of remaining graft particles	6 months	Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure

Trial Locations

Locations (2)

Universidad de Valencia; 🇪🇸 Valencia, Spain

University of Granada; 🇪🇸 Granada, Spain