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Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05577520
Enrollment
20
Registered
2022-10-13
Start date
2016-03-01
Completion date
2019-08-30
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Augmentation

Keywords

Sinus floor augmentation, Xenograft, Anorganic, Bovine bone, Histomorphometry

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).

Interventions

PROCEDURESinus floor augmentation

Sponsors

Universidad del Salvador, Argentina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of newly formed bone (NB)10 monthhistomorphometric parameter was assessed in a standardized area
Percentage of bone substitute10 monthhistomorphometric parameter was assessed in a standardized area
Percentage of bone marrow10 monthhistomorphometric parameter was assessed in a standardized area
Percentage of osseointegration10 monthhistomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026