About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Leukocyte Platelet Rich Fibrin
Biological/VaccineL-PRF does not directly induce bone formation within the maxillary sinus; rather, it serves as an autologous biologic scaffold that facilitates the regenerative process
Treatment groups
Trial outcomes
Primary outcomes
Maxillary Sinus Volume using 2D imaging
Regular x-rays are used to take measurements
Maxillary Sinus Volume using 3D imaging
3D CBCT images are used for measurements
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: