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

Study Overview
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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.

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

Conditions
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Sinus Floor Augmentation

Intervention / Treatment
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* Device: Biphasic phycogenic biomaterial
* Device: Xenograft bovine hydroxyapatite


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biphasic phycogenic biomaterial<br>Biphasic phycogenic biomaterial and Autogenous cortical bone | Device: Biphasic phycogenic biomaterial<br>* Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone<br>|
| Experimental: Xenograft bovine hydroxyapatite<br>Xenograft bovine hydroxyapatite and Autogenous cortical bone | Device: Xenograft bovine hydroxyapatite<br>* Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maxillary sinus augmentation, Sinus lift, Biomaterial, Anorganic bovine bone, Phicogenic biomaterial, Implant Dentistry