An interventional study of DFDBA fibers and DFDBA particles in Bone Loss in Jaw, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
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.
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.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's enrollment of 26 is below the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After standard of care elevation of the Schneiderian membrane, a mix of DFDBA fibers with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.
Device: DFDBA fibers · Device: DBBM
After standard of care elevation of the Schneiderian membrane, a mix of DFDBA particles with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.
Device: DFDBA particles · Device: DBBM
Bone Allograft fibers used in dental sinus reconstruction surgery
Also known as: Demineralized Freeze Dried Bone Allograft Fibers
Bone Allograft particles used in dental sinus reconstruction surgery
Also known as: Demineralized Freeze Dried Bone Allograft Particles
DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.
Also known as: Deproteinized Bovine Bone Mineral
Percent Vital Bone Formation
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.
Time frame: Baseline to 6 months
Plan to share: Yes — All collected de-identified Individual Participant data (IPD) that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: When summary data are published or otherwise made available
No publications or documents are linked to this record.
Ran from Sep 2023 to primary completion in Feb 2026, 28 months.
Of 71 non-industry interventional studies with no phase under Tooth Loss, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 28 months is close to that.
Counting every sponsor, half of 77 studies reached it within 28 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio →