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

Not Applicable

Completed

• Conditions: Sinus Floor Augmentation
• Interventions: Device: Biphasic phycogenic biomaterial; Device: Xenograft bovine hydroxyapatite

• Registration Number: NCT03682315
• Lead Sponsor: Universidad de Granada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2018-04
• Study Completion: 2018-05
• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-20
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biphasic phycogenic biomaterial	Biphasic phycogenic biomaterial	Biphasic phycogenic biomaterial and Autogenous cortical bone
Xenograft bovine hydroxyapatite	Xenograft bovine hydroxyapatite	Xenograft bovine hydroxyapatite and Autogenous cortical bone

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Facultad de Odontología; 🇪🇸 Granada, Spain