Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

Study Overview
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Brief Summary
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The decrease in maxillary alveolar ridge bone volume and sinus pneumatization are a challenge to implant-assisted prosthetic rehabilitation. Guided bone regeneration using bone substitutes is an adequate alternative for maxillary sinus augmentation. Objective: To histologically and histomorphometrically compare bone repair response to 250 to 1000 µm and 1000 to 2000 µm anorganic bovine bone mineral (ABBM) particles as bone substitute in maxillary sinus augmentation (MSA).

Detailed Description
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Twenty patients were treated with SMA in two steps. They were randomly assigned to one of two groups (n=10): SPG (small particles group) and LPG (large particles group). Different size ABBM particles were implanted in their maxillary sinus, accordingly. A vertical bone core biopsy was obtained at the implant site using a punch trephine. The samples were processed for histological observation and measured histomorphometrically to determine the percentage onewly formed bone (%NB), bone substitute (%BS), bone marrow (%BM), and osseointegration (%OI). Results were statistically analyzed using Student's t test (p ≤ 0.05).

Official Title
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Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles: a Histomorfometric Comparison

Conditions
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Maxillary Sinus Augmentation

Intervention / Treatment
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* Procedure: Sinus floor augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients over the age of 21 years Patients missing teeth in the maxillary sinus region (uni- or bilaterally) with a residual subantral bone height ≤ 4 mm and an alveolar ridge width ≥ 6mm. Patients who had not undergone tooth extraction within 6 months prior to enrollment. Exclusion Criteria: Patients with diabetes, blood discrasias, a history of head and neck chemotherapy/radiation therapy, acute sinusitis or a history of allergic sinusitis, chronic polypoid sinusitis, or sinus tumors, or a history of Caldwell-Luc surgery Women who were pregnant or of childbearing age Alcoholics and drug abusers Patients requiring MS treatment showing anatomical features of the MS that contraindicated the surgical treatment Patients who refused to sign the informed consent form Patients with a history of chronic periodontitis were treated and then enrolled in the study. Patients who developed post-operative maxillary sinus infection or showed allergic reactions attributable to the grafting material were eliminated from the study.

Ages Eligible for Study
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Minimum Age: 21 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: Small particle group (SPG n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. Large particles group (LPG n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small particle group (SPG)<br>SPG (n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. | Procedure: Sinus floor augmentation<br> <br> * Other names: Sinus floor elevation;|
| Experimental: Large particles group (LPG)<br>LPG (n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. | Procedure: Sinus floor augmentation<br> <br> * Other names: Sinus floor elevation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of newly formed bone (NB) | histomorphometric parameter was assessed in a standardized area | 10 month | 
| Percentage of bone substitute | histomorphometric parameter was assessed in a standardized area | 10 month | 
| Percentage of bone marrow | histomorphometric parameter was assessed in a standardized area | 10 month | 
| Percentage of osseointegration | histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration | 10 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xenograft, Sinus floor augmentation, Anorganic, Bovine bone, Histomorphometry