PLGA-coated Biphasic Calcium Phosphate in Sinus Lift

NCT03474627 | Completed

• 1 other identifier: H1452514461215
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Sinus Floor Augmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Area of new mineralized tissue

  6 months

• Area of non-mineralized tissue

  6 months

• Area of remaining graft particles

  6 months

Study Arms (2)

Non-coated HA/TCP particles

ACTIVE COMPARATOR

Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft

Device: Non-coated HA/TCP particles

PLGA-coated HA/TCP particles

EXPERIMENTAL

Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating

Device: PLGA-coated HA/TCP particles

Interventions

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

Non-coated HA/TCP particles

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

PLGA-coated HA/TCP particles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Sinus pathology (sinusitis, mucocele, cysts).
• Smokers.
• Previous long-term (\>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

Sponsors & Collaborators

• Universidad de Granada: lead
• University of Valencia: collaborator

Study Sites (2)

University of Granada

Granada, 18071, Spain

Location

Universidad de Valencia

Valencia, 46010, Spain

Location

Related Publications (4)

• 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.

  PMID: 22376122 BACKGROUND

• 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.

  PMID: 28854415 BACKGROUND

• 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.

  PMID: 17355356 BACKGROUND

• 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.

  PMID: 29071736 BACKGROUND

Study Officials

• Antonio J Flichy-Fernandez, DDS

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Oral Surgery and Implant Dentistry

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 22, 2018
• Study Start: February 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)