NCT06173791

Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation

Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation: A Double Arm Randomized Control And Histomorphometric Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM. The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.

Detailed description

This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing maxillary sinus augmentation will be enrolled. There will be two subject groups in this study both of which will randomized to one of two standard care procedures. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups a bone sample (core) will be obtained as a by-product of implant placement. Bone will not be extracted solely for research purposes, the bone sample attained for research will only be from bone left over after the SOC implant placement. Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.

Conditions

• Bone Loss in Jaw

Interventions

Type	Name	Description
DEVICE	DFDBA fibers	Bone Allograft fibers used in dental sinus reconstruction surgery
DEVICE	DFDBA particles	Bone Allograft particles used in dental sinus reconstruction surgery
DEVICE	DBBM	DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.

Timeline

• Start date: 2023-09-25
• Primary completion: 2026-02-10
• Completion: 2026-02-10
• First posted: 2023-12-18
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study