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Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

U

Universidad del Salvador, Argentina

Status

Completed

Conditions

Maxillary Sinus Augmentation

Treatments

Procedure: Sinus floor augmentation

Study type

Interventional

Funder types

Other

Identifiers

NCT05577520
VRDI 1801

Details and patient eligibility

About

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).

Full 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).

Enrollment

20 patients

Sex

All

Ages

21+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Small particle group (SPG)
Experimental group
Description:
SPG (n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.
Treatment:
Procedure: Sinus floor augmentation
Large particles group (LPG)
Experimental group
Description:
LPG (n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.
Treatment:
Procedure: Sinus floor augmentation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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