Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

Sponsor

Universidad del Salvador, Argentina (Other)

Overall Status

Completed

CT.gov ID

NCT05577520

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Maxillary Sinus Augmentation	Procedure: Sinus floor augmentation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Feb 25, 2018

Actual Study Completion Date :

Aug 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage of newly formed bone (NB) [10 month]
histomorphometric parameter was assessed in a standardized area
Percentage of bone substitute [10 month]
histomorphometric parameter was assessed in a standardized area
Percentage of bone marrow [10 month]
histomorphometric parameter was assessed in a standardized area
Percentage of osseointegration [10 month]
histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association	Buenos Aires		Argentina	1125

Sponsors and Collaborators

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)