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OpenTrials
Completed

NCT Number: NCT05577520

Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

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).

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association

Buenos Aires, 1125, Argentina

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sinus floor augmentation

Procedure

Other names: Sinus floor lift, Sinus floor elevation

Primary outcomes

  1. Percentage of newly formed bone (NB)

    Time frame: 10 month

    histomorphometric parameter was assessed in a standardized area

  2. Percentage of bone substitute

    Time frame: 10 month

    histomorphometric parameter was assessed in a standardized area

  3. Percentage of bone marrow

    Time frame: 10 month

    histomorphometric parameter was assessed in a standardized area

  4. Percentage of osseointegration

    Time frame: 10 month

    histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration

Sponsors and collaborators

Lead sponsor

Universidad del Salvador, Argentina

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 13, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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