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

Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03682315

Enrollment

Registered

2018-09-24

Start date

2016-09-30

Completion date

2018-05-31

Last updated

2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus Floor Augmentation

Keywords

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

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.

Interventions

DEVICEBiphasic phycogenic biomaterial

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

DEVICEXenograft bovine hydroxyapatite

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Sinus floor height change	From surgery to 6 months	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

Secondary

Measure	Time frame	Description
Area of new mineralized tissue	6 months	Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Area of non-mineralized tissue	6 months	Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Area of remaining graft particles	6 months	Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026