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Bone Graft

DFDBA Particles with DBBM for Jawbone Loss

N/A
Recruiting
Led By Angela Palaiologou-Gallis, DDS, MS
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients between age 18 and 89
Patients needing sinus augmentation to support implant placement in the posterior maxilla
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights

Study Summary

This trial will test if adding DFDBA fibers to DBBM results in more new bone than adding DFDBA particles to DBBM during a sinus augmentation procedure.

Who is the study for?
This trial is for individuals experiencing jawbone loss who require sinus augmentation, a type of dental surgery. Participants must be healthy enough for the procedure and not have conditions that could interfere with bone healing or the study's outcomes.Check my eligibility
What is being tested?
The trial is testing two different materials used in sinus augmentation: DFDBA fibers versus DFDBA particles, both added to another material called DBBM. The goal is to see which combination leads to better bone formation after six months.See study design
What are the potential side effects?
While specific side effects are not listed, common risks associated with sinus augmentation may include infection, bleeding, swelling, pain at the implant site, and possible rejection of the graft material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 89 years old.
Select...
I need a procedure to prepare for dental implants in the upper back part of my mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Vital Bone Formation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DFDBA Particles with DBBMExperimental Treatment2 Interventions
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.
Group II: DFDBA Fibers with DBBMActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
453 Previous Clinical Trials
91,404 Total Patients Enrolled
Angela Palaiologou-Gallis, DDS, MSPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
1 Previous Clinical Trials
6 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this medical experiment?

"This clinical trial is currently enrolling a maximum of 26 patients who have suffered jawbone loss and are aged between 18-89."

Answered by AI

Can adults over the age of 45 partake in this medical experiment?

"This research trial is welcoming participants over the age of 18 and those under 89 years old."

Answered by AI

What is the upper limit for enrolling participants in this clinical trial?

"Affirmative. According to the clinicaltrials.gov repository, this clinical investigation began on September 25th 2023 and is presently in search of 26 patients for enrollment from a single medical institution."

Answered by AI

Are there still opportunities for patients to enroll in this experiment?

"Affirmative. According to the clinicaltrials.gov database, this medical study is currently seeking participants. The trial was first posted on September 25th 2023 and has since been updated on December 7th of that same year. This research requires 26 individuals from a single site for successful completion."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
University of Texas Health Science Center at San Antonio

Why did patients apply to this trial?

I need whole mouth implants and possible work on jaw bone . The back quads of upper and lower gone. I can’t afford to get implants and desperately need them to eat and feel good about my appearance again.
PatientReceived 2+ prior treatments
~16 spots leftby May 2025