NCT03639077

Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Similarly, implant placement will be performed and results will be evaluated after a period of six months.

Detailed description

This will be a prospective clinical study evaluating the stability and volumetric change of two grafting materials used in lateral window sinus augmentation procedure (anorganic bovine bone xenograft alone compared to a mixture of allograft and anorganic bovine bone xenograft). Participants will have the same surgical treatment of the lateral window sinus augmentation procedure. Participants will have a simultaneous implant placement at the time of sinus augmentation procedure or a delayed implant placement based on the stability of the implant evaluation. Cone beam computed tomography (CBCT) will be used to evaluate the volumetric changes between two groups of graft material in sinus augmentation procedure at three time points: pre-operatively, two weeks post-operation and six months post-operation. Biopsies will be harvested after six months for histological and histomorphometric analysis.

Conditions

• Lateral Window Sinus Augmentation

Interventions

Type	Name	Description
DEVICE	Allograft bone alone	The subject will receive an allograft as graft material of choice for sinus augmentation
DEVICE	Allograft and xenograft mixture	The subjects will receive a mixture of allograft and anorganic bovine bone xenograft as graft material of choice for sinus augmentation

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-04-24
• Completion: 2020-09-09
• First posted: 2018-08-20
• Last updated: 2024-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study