Bone Loss in JawNCT06173791
Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation
A study testing DFDBA fibers, DFDBA particles and DBBM in people with Bone Loss in Jaw, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss in Jaw
- What is being tested?
- DFDBA fibers, DFDBA particles and DBBM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation: A Double Arm Randomized Control And Histomorphometric Study
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.
Read the 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
- Being tested
- DFDBA fibers, DFDBA particles, DBBM
- Keywords
- Tooth loss, Bone Resorption, Xenograft, Allograft
- Medical subject headings
- Tooth Loss, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFDBA fibersDevice
Also called Demineralized Freeze Dried Bone Allograft Fibers
Bone Allograft fibers used in dental sinus reconstruction surgery
DFDBA particlesDevice
Also called Demineralized Freeze Dried Bone Allograft Particles
Bone Allograft particles used in dental sinus reconstruction surgery
DBBMDevice
Also called Deproteinized Bovine Bone Mineral
DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.
| Study group | Role | What they receive |
|---|---|---|
| DFDBA Fibers with DBBM | Active comparator | 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. Receives: Device: DFDBA fibers; Device: DBBM |
| DFDBA Particles with DBBM | Other | 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. Receives: Device: DFDBA particles; Device: DBBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start25 Sep 2023
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss in JawStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio
- Investigators
- Angela Palaiologou-Gallis, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173791
- Sponsor's protocol ID
- HSC20230387H
- Status last verified
- Feb 2026
- First submitted
- 7 Dec 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected de-identified Individual Participant data (IPD) that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation: A Double Arm Randomized Control And Histomorphometric Study
- ClinicalTrials.gov ID
- NCT06173791
- Acronym / sponsor ID
- HSC20230387H
- Conditions
- Bone Loss in Jaw
- Keywords
- Tooth loss, Bone Resorption, Xenograft, Allograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques
| Arm | Type | Receives |
|---|---|---|
| DFDBA Fibers with DBBM | Active comparator | Device: DFDBA fibers, Device: DBBMAfter 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. |
| DFDBA Particles with DBBM | Other | Device: DFDBA particles, Device: DBBMAfter 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFDBA fibersAlso: Demineralized Freeze Dried Bone Allograft FibersBone Allograft fibers used in dental sinus reconstruction surgery | Device | DFDBA Fibers with DBBM |
| DFDBA particlesAlso: Demineralized Freeze Dried Bone Allograft ParticlesBone Allograft particles used in dental sinus reconstruction surgery | Device | DFDBA Particles with DBBM |
| DBBMAlso: Deproteinized Bovine Bone MineralDBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth. | Device | DFDBA Fibers with DBBM, DFDBA Particles with DBBM |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. All collected de-identified Individual Participant data (IPD) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Palaiologou-Gallis, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DFDBA fibers, DFDBA particles and DBBM in people with Bone Loss in Jaw, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Vital Bone Formation (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.