What this study is
An examination of the participants mouth is done first. If they do not have enough bone to place a dental implant as a tooth replacement, and they have chosen sinus augmentation to treat this issue during implant placement a leukocyte platelet rich fibrin (L-PRF) will be performed instead of using other available options. The only difference from usual care is that L-PRF alone will be used as the bone formation material and two additional x-rays, Cone Beam Computed Tomography (CBCTs) will be taken right after the procedure and then again six months after treatment. CBCT is a special type of 3D X-ray commonly used in dentistry and oral surgery. Unlike traditional X-rays, which create flat 2D images, CBCT produces detailed 3D images of your teeth, jawbone, nerves, and nearby tissues.
What's being tested
- Leukocyte Platelet Rich Fibrin
Intervention · BIOLOGICAL
L-PRF does not directly induce bone formation within the maxillary sinus; rather, it serves as an autologous biologic scaffold that facilitates the regenerative process
Study details
- Official title
- Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin (L-PRF)
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Conditions
- Partially Edentulous Maxilla
- Enrolling
- 25 people
- Starts
- 2027-01
- Est. completion
- 2029-01
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Ability of participant to understand and the willingness to sign a written informed consent document.
- English speaking.
- Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c < 7.0.
- Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement
- At minimum 5mm of native bone below the maxillary sinus inferior border
You can't join if
- Maxillary sinus disease
- Diabetes diagnosis with a current HbA1c > 7.1 or greater, or if HbA1c status cannot be confirmed, due to diabetes effect on bone metabolism
- Pregnant or attempting to become pregnant
- Having a disease that affects bone metabolism
- Use of medications known to affect bone metabolism
- Tobacco, cannabis or vaping use
- Alcoholism or other recreational drugs
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
- Charles Powell, DDS, MS · Contact210-567-3539powellc2@uthscsa.edu
Study team
Sponsor
The University of Texas Health Science Center at San Antonio
Study ID STUDY00002807
Principal investigator
Charles A Powell, DDS, MS
The University of Texas Health Science Center at San Antonio
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.