Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

Not Applicable

Completed

• Conditions: Maxillary Sinus Augmentation
• Interventions: Procedure: Sinus floor augmentation

• Registration Number: NCT05577520
• Lead Sponsor: Universidad del Salvador, Argentina

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).

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2018-02-25
• Study Completion: 2019-08-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-09
• Last Update Submitted: 2022-10-09
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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