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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sinus Floor Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Biphasic phycogenic biomaterial

Biphasic phycogenic biomaterial and Autogenous cortical bone

Group Type ACTIVE_COMPARATOR

Biphasic phycogenic biomaterial

Intervention Type DEVICE

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

Xenograft bovine hydroxyapatite

Xenograft bovine hydroxyapatite and Autogenous cortical bone

Group Type EXPERIMENTAL

Xenograft bovine hydroxyapatite

Intervention Type DEVICE

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

Interventions

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Biphasic phycogenic biomaterial

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

Intervention Type DEVICE

Xenograft bovine hydroxyapatite

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No