PLGA-coated Biphasic Calcium Phosphate in Sinus Lift

Sinus Floor Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474627
• Other study ID #: H1452514461215
• Status: Completed
• Phase: N/A
• First received: March 15, 2018
• Last updated: March 15, 2018
• Start date: February 2012
• Est. completion date: March 2017

Study information

• Verified date: March 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2017
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sinus Floor Augmentation

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	University of Granada	Granada
Spain	Universidad de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Galindo-Moreno P, Avila G, Fernández-Barbero JE, Aguilar M, Sánchez-Fernández 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. Epub 2007 Mar 12. — View Citation

Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernández-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. — View Citation

Galindo-Moreno P, Hernández-Cortés P, Mesa F, Carranza N, Juodzbalys G, Aguilar M, O'Valle F. Slow resorption of anorganic bovine bone by osteoclasts in maxillary sinus augmentation. Clin Implant Dent Relat Res. 2013 Dec;15(6):858-66. doi: 10.1111/j.1708-8208.2012.00445.x. Epub 2012 Feb 29. — View Citation

Ortega-Oller I, Del Castillo-Santaella T, Padial-Molina M, Galindo-Moreno P, Jódar-Reyes AB, Peula-García JM. Dual delivery nanosystem for biomolecules. Formulation, characterization, and in vitro release. Colloids Surf B Biointerfaces. 2017 Nov 1;159:586-595. doi: 10.1016/j.colsurfb.2017.08.027. Epub 2017 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinus floor height change	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.	6 months
Secondary	Area of new mineralized tissue	Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure	6 months
Secondary	Area of non-mineralized tissue	Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure	6 months
Secondary	Area of remaining graft particles	Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure	6 months