Clinical trial NCT03682315: Comparison of Phicogenic vs. Xenogeneic Biomaterial for Maxillary Sinus Floor Elevation
Official title: Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Floor Augmentation
Keywords: Maxillary sinus augmentation
Sinus lift
Biomaterial
Anorganic bovine bone
Phicogenic biomaterial
Implant Dentistry
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 8
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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

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: From surgery to 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: Facultad de Odontología
Study officials:
affiliation: Universidad de Granada
name: Pablo Galindo-Moreno, DDS, PhD, MS
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: 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.
citation: 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.