Clinical trial NCT03474627: PLGA-coated Biphasic Calcium Phosphate in Sinus Lift
Official title: Sinus Floor Elevation Using Particulate and in Situ Hardening Biphasic Calcium Phosphate Bone Graft Substitutes: A Prospective Histological and Radiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Floor Augmentation
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2018-03-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sinus floor height change
timeFrame: 6 months
Secondary outcomes:
measure: Area of new mineralized tissue
timeFrame: 6 months
measure: Area of non-mineralized tissue
timeFrame: 6 months
measure: Area of remaining graft particles
timeFrame: 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
city: Valencia
country: Spain
facility: Universidad de Valencia
Study officials:
affiliation: University of Valencia
name: Antonio J Flichy-Fernandez, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galindo-Moreno P, Hernandez-Cortes 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.
citation: Ortega-Oller I, Del Castillo-Santaella T, Padial-Molina M, Galindo-Moreno P, Jodar-Reyes AB, Peula-Garcia 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.
citation: Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez 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. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.
citation: Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-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.