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Completed

NCT Number: NCT01911819

A Comparison of Bone Formation With Three Different Bone Graft Materials Following Sinus Graft

The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University School of Dentistry

Loma Linda, California, 92350, United States

About this study

The purpose of this investigation is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using three different bone graft materials. Null Hypothesis is that there is no histomorphometric difference in new bone formation in maxillary sinuses augmented using three different materials; anorganic bovine bone graft (Bio-Oss), anorganic equine bone graft (Equimatrix) and mineralized bone allograft (OSSIF-i sem). Patients who require sinus augmentation prior to implant placement will be selected to participate in this study. All patients will be randomly placed into three groups according to bone graft materials that will be used. Group A (Control group,n=10): Maxillary sinus augmentation using anorganic bovine bone graft (Bio-Oss), Group B (Test group,n=10):Maxillary sinus augmentation using anorganic equine bone graft (Equimatrix), and Group C (Test group,n=10):Maxillary sinus augmentation using mineralized bone allograft (OSSIF-i sem). All the patients will be treated with the same surgical technique consisting of sinus floor augmentation via a lateral approach.After a full-thickness flap reflection to expose the lateral wall of the sinus each antrostomy will be outlined with a carbide round bur and sinus membranes will be carefully elevated. If a perforation to the sinus membrane occurs, and if the perforation is < 5 mm in diameter and is able to be repaired, the surgeon will continue the procedure. Any perforation > 5 mm will be excluded from this study. Bone graft materials will be placed into the each sinus compartment for the three groups. After 8 months of healing, biopsy specimen will be collected from the previous antrostomy sites. Histomorphometric measurements of the percentage of vital bone of the area of bone. The percentage of non-bone material (allograft or xenograft) and the percentage of connective tissue will be also analyzed. Then the primary hypothesis will be analyzed statistically.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Over 18 years old who are able to read and sign written consent form.
  • Patient who has good oral hygiene (Full-mouth plaque score <25%).
  • Subject would be available for study monitoring.
  • Patients with missing teeth in the maxillary posterior region who will require sinus augmentation f or implant placement. The patients may be partially or completely edentulous.
  • Delayed implant placement approximately 8 months following sinus grafting.

Exclusion criteria

A medical history that will complicate the outcome of the study such as:

  • alcohol, drug dependency,
  • signs or symptoms of maxillary sinus disease,
  • current smoker,
  • history of head and neck radiation treatment,
  • poor health or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.

Treatment and study plan

Sinus augmentation

Procedure

Equimatrix

Drug

Equimatrix cancellous particle size 0.2-1mm approximately 2g (4cc)

OSSIF-i sem

Drug

OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 2cc x 2

Bio-oss

Drug

Bio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc)

Primary outcomes

  1. The Percentage of Vital Bone in a Total Amount of a Bone Specimen

    Time frame: 24months

    Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.

Secondary outcomes

  1. The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.

    Time frame: 24months

    Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • American Regent, Inc.

Registry information

Official study title

A Histomorphometric Analysis of Bone Formation With Three Different Bone Graft Materials Following Sinus Augmentation

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2013
Registry last updated
Dec 13, 2017

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.