PLGA-coated Biphasic Calcium Phosphate in Sinus Lift

Study Overview
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Brief Summary
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The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening properties. A randomized clinical study is designed to include patients in need of two-stage sinus floor elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies are obtained at the site of implant placement. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.

Official Title
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Sinus Floor Elevation Using Particulate and in Situ Hardening Biphasic Calcium Phosphate Bone Graft Substitutes: A Prospective Histological and Radiological Study

Conditions
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Sinus Floor Augmentation

Intervention / Treatment
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* Device: Non-coated HA/TCP particles
* Device: PLGA-coated HA/TCP particles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partially edentulous patients. Kennedy class I or II in the upper jaw, from first premolar to second molar. Less than 5 mm of residual crestal bone. 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: Non-coated HA/TCP particles<br>Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft | Device: Non-coated HA/TCP particles<br>* Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft<br>|
| Experimental: PLGA-coated HA/TCP particles<br>Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating | Device: PLGA-coated HA/TCP particles<br>* Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating<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 measure vertical bone height from the crestal bone to the floor of the maxillary sinus. | 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 |