NCT03059914

A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.

A Histomorphometric Analysis of New Bone Formation Following Sinus Augmentation Using Two Different Bone Graft Materials. A Pilot Study in Humans.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 103 Years
• Healthy volunteers: Accepted

Summary

The purpose of this investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. A total of twenty, sinus augmentation via a lateral approach will be performed for subjects requiring sinus augmentation for implant placement and randomly divided into 2 groups. These subjects will receive one of two different bone graft materials: 1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss (Group B). At the time of implant placement (eight months after the sinus augmentation procedure), two bone biopsies will be collected from augmented site for the histomorphometric analysis. The percentage of vital bone will be measured and analyzed statistically, also the following will be measured: percentage of non-vital bone, percentage of non-bone material , and the percentage of connective tissue.

Detailed description

Bovine xenograft has been established as a gold standard in maxillary sinus floor augmentation. This study was initiated to compare two different types of bovine xenografts following maxillary sinus floor augmentation. The comparison will performed using histomorphometric analysis of bone cores removed from the grafted sites. The patients that meet the guidelines for maxillary sinus floor augmentation via lateral window approach are randomly assigned into control and test groups. The surgery is performed by the same surgeon under the same protocols. The subjects in Group A - test group receive InterOss bone graft and subjects in Group B- Control Group receive BioOss bone graft. After eight months of healing at the sites, the patients are subjected to CBCT evaluation in preparation for implant placement. At the time of implant placement the two bone cores are collected from each grafted site using trephine burs. One bone core is collected from the crestal bone that will be site of implant placement and the second bone core is collected from the lateral window area not to interfere with the implant site. These bone cores are stored intact inside the trephine burs, fixed, stored and transported to the lab for histomorphometric analysis. The following parameters are measured and reported after the histomorphometric analysis. percentage of vital bone percentage of non-vital bone ( graft material) percentage of non-bone material percentage of connective tissue.

Conditions

• Missing Teeth

Interventions

Type	Name	Description
DEVICE	InterOss	Anorganic bovine bone mineral - Xenograft
DEVICE	Bio-oss	Anorganic bovine bone mineral ( Xenograft)

Timeline

• Start date: 2017-08-10
• Primary completion: 2020-06-26
• Completion: 2020-06-26
• First posted: 2017-02-23
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study