Comparative Results of Six Biomaterials Used in Two-stage Maxillary Sinus

Study Overview
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Brief Summary
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Objectives: The aim of the study was to compare histological and histomorphometric results of six bone substitute materials used as graft in two-stage maxillary sinus augmentation model, after 6-month-healing.

Detailed Description
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Materials and Methods: A two-stage sinus augmentation was carried out in six patients using mineralized solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA), anor-ganic bovine bone (ABB), equine-derived bone (EB); synthetic micromacroporous biphasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyap-atite (HA-β-TCP 30/70), or bioapatite-collagen (BC).

Official Title
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Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-stage Maxillary Sinus Augmentation Model After 6-month-healing

Conditions
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Atrophy, Jaw, Edentulous, Partially, Sinus Floor Augmentation, Bone Substitutes, Bone Regeneration

Intervention / Treatment
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* Procedure: Sinus floor augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients healthy, absence of systemic pathologies (ASA class I), non-smokers, good oral hygiene, not pregnant or lactating, absence of painful symptoms and associated inflammatory or osteolytic pathologies, maxillary partial edentulism involving the premolar/molar areas, residual bone height between the sinus floor and alveolar ridge ranging from 2 to 4 mm, as measured on computerized tomography (CT) scan. - Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 33 Years
Maximum Age: 70 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
Interventional Model Description: A randomized,controlled, double-blind clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bone substitute material MCBA<br>Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using mineralized sol-vent-dehydrated bone allograft material. | Procedure: Sinus floor augmentation<br> <br> |
| Active Comparator: bone substitute material FDBA<br>Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using freeze-dried mineralized bone allograft material. | Procedure: Sinus floor augmentation<br> <br> |
| Active Comparator: bone substitute material ABB<br>Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using anorganic bovine bone material. | Procedure: Sinus floor augmentation<br> <br> |
| Active Comparator: bone substitute material EB<br>Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using equine-derived bone material. | Procedure: Sinus floor augmentation<br> <br> |
| Active Comparator: bone substitute material HA-β-TCP 30/70<br>Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using synthetic micromacroporous bi-phasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hy-droxyapatite material. | Procedure: Sinus floor augmentation<br> <br> |
| Active Comparator: bone substitute material BC<br>Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using bioapatite-collagen material. | Procedure: Sinus floor augmentation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to perform biopsies from each six augmented site using to compare, histologically and histomorphometrically, the percentages of newly formed bone, residual grafted material, and marrow spaces. | After 6 months clinical and radiographic examinations were undertaken and each patient was reappointed for biopsy at the time of implant placement in the same location. Under local anesthesia, a full thickness flap was raised, a biopsy was performed using a 3.5 mm tre-phine bur under sterile saline solution irrigation, guided by the radiographic/surgical template in the selected implant site. A total of six bone samples was retrieved from the occlusal aspect to the alveolar crest, one from each augmented site to compare histologically and histomorphometrically the different materials. | 6 month-healing after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus floor augmentation, Bone regeneration, Histology, Biocompatible materials, Bone transplantation