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

Universidad del Salvador, Argentina1 site in 1 country20 target enrollmentMarch 1, 2016

ConditionsMaxillary Sinus Augmentation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Maxillary Sinus Augmentation
Sponsor: Universidad del Salvador, Argentina
Enrollment: 20
Locations: 1
Primary Endpoint: Percentage of newly formed bone (NB)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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).

Registry

clinicaltrials.gov

Start Date

March 1, 2016

End Date

August 30, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad del Salvador, Argentina

Responsible Party

Principal Investigator

Jorge Ernesto Aguilar

Director and Professor, Oral Implantology Program

Universidad del Salvador, Argentina

Eligibility Criteria

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.