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OpenTrials
Completed

NCT Number: NCT06173791

Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients between age 18 and 89
  • Patients needing sinus augmentation to support implant placement in the posterior maxilla
  • Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report
  • Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.

Exclusion criteria

  • Patients who disclose that they will not be able to cooperate with the follow-up schedule.
  • Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
  • Pregnant women or women intending to become pregnant during study period
  • Smokers who smoke > 10 cigarettes per day

Treatment and study plan

DFDBA fibers

Device

Bone Allograft fibers used in dental sinus reconstruction surgery

Other names: Demineralized Freeze Dried Bone Allograft Fibers

DFDBA particles

Device

Bone Allograft particles used in dental sinus reconstruction surgery

Other names: Demineralized Freeze Dried Bone Allograft Particles

DBBM

Device

DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.

Other names: Deproteinized Bovine Bone Mineral

Primary outcomes

  1. Percent Vital Bone Formation

    Time frame: Baseline to 6 months

    Each side of the maxillary sinus will be used as a separate unit of analysis. The assumption is that each patient will have only one side of the maxillary sinus; however, it is common for some patients to need both maxillary sinuses augmented (2 sites in a single patient). Change in vital bone formation will be measured from baseline (surgery) to 6 months post surgery.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2023
Registry last updated
Feb 20, 2026

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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