Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

October 9, 2022 updated by: Jorge Ernesto Aguilar, Universidad del Salvador, Argentina

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1125
        • Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Salvador, Argentina

Investigators

  • Principal Investigator: jorge aguilar, Chair Prof., Salvador University /Argentine Dental Association (USAL/AOA)
  • Study Director: Sandra Renou, Assoc. Prof., Buenos Aires University (Argentine)
  • Principal Investigator: Alicia Labandeira, Chair Prof., Salvador University /Argentine Dental Association (USAL/AOA)
  • Principal Investigator: Maria Piloni, Assoc. Prof., Buenos Aires University (Argentine)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

February 25, 2018

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

October 9, 2022

First Submitted That Met QC Criteria

October 9, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 9, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VRDI 1801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Maxillary Sinus Augmentation

Clinical Trials on Sinus floor augmentation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe