Comparison of Phicogenic vs. Xenogeneic Biomaterial for Maxillary Sinus Floor Elevation

NCT03682315 | Completed

• 1 other identifier: 307CEIH2017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using a biphasic phicogenic biomaterial in comparison with anorganic bovine bone. A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients are assigned to receive a mix of autogenous bone and a biphasic phycogenic biomaterial in one maxillary sinus and a mix of autogenous bone and xenograft bovine hydroxyapatite in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans are performed before sinus floor elevation and 6 months after the procedure to assess the bone gain. Bone core biopsies are obtained at the site of implant placement 6 months after the floor elevation. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.

Conditions

Sinus Floor Augmentation

Keywords

Maxillary sinus augmentation; Sinus lift; Biomaterial; Anorganic bovine bone; Phicogenic biomaterial; Implant Dentistry

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 calculate vertical bone height change from the crestal bone to the floor of the maxillary sinus

  From surgery to 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)

Biphasic phycogenic biomaterial

ACTIVE COMPARATOR

Biphasic phycogenic biomaterial and Autogenous cortical bone

Device: Biphasic phycogenic biomaterial

Xenograft bovine hydroxyapatite

EXPERIMENTAL

Xenograft bovine hydroxyapatite and Autogenous cortical bone

Device: Xenograft bovine hydroxyapatite

Interventions

Biphasic phycogenic biomaterial DEVICE

Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone

Biphasic phycogenic biomaterial

Xenograft bovine hydroxyapatite DEVICE

Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone

Xenograft bovine hydroxyapatite

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 in the upper jaw.
• Less than 5 mm of residual crestal bone to the maxillary sinus.
• 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

Study Sites (1)

Facultad de Odontología

Granada, 18071, 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

• 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

• Galindo-Moreno P, Padial-Molina M, Lopez-Chaichio L, Gutierrez-Garrido L, Martin-Morales N, O'Valle F. Algae-derived hydroxyapatite behavior as bone biomaterial in comparison with anorganic bovine bone: A split-mouth clinical, radiological, and histologic randomized study in humans. Clin Oral Implants Res. 2020 Jun;31(6):536-548. doi: 10.1111/clr.13590. Epub 2020 Mar 6.

  PMID: 32072685 RESULT

Study Officials

• Pablo Galindo-Moreno, DDS, PhD, MS

  Universidad de Granada

  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: September 21, 2018
• First Posted: September 24, 2018
• Study Start: September 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)