Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe University of Texas Health Science Center at San Antonio

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Leukocyte Platelet Rich Fibrin

    Biological/Vaccine

    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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Sinus Augmentation with Implant placementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maxillary Sinus Volume using 2D imaging

Regular x-rays are used to take measurements

Time frame
Baseline to 6 months
2

Maxillary Sinus Volume using 3D imaging

3D CBCT images are used for measurements

Time frame
Baseline to 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: