Clinical trial NCT05577520: Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles
Official title: Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles: a Histomorfometric Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus Augmentation
Keywords: Sinus floor augmentation
Xenograft
Anorganic
Bovine bone
Histomorphometry
Lead sponsor: Universidad del Salvador, Argentina
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percentage of newly formed bone (NB)
timeFrame: 10 month
measure: Percentage of bone substitute
timeFrame: 10 month
measure: Percentage of bone marrow
timeFrame: 10 month
measure: Percentage of osseointegration
timeFrame: 10 month
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association
Study officials:
affiliation: Salvador University /Argentine Dental Association (USAL/AOA)
name: jorge aguilar, Chair Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Buenos Aires University (Argentine)
name: Sandra Renou, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Salvador University /Argentine Dental Association (USAL/AOA)
name: Alicia Labandeira, Chair Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Buenos Aires University (Argentine)
name: Maria Piloni, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
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