Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin (L-PRF)
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Maxillary Sinus Volume using 2D imaging
Study Overview
Brief Summary
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.
Detailed Description
Prior to surgery, a detailed radiographic assessment is performed utilizing a limited volume CBCT and periapical radiographs (PA). During the implant planning phase, a careful evaluation of the implant's positioning and angulation will be conducted based on the preoperative CBCT images. On the day of the surgical appointment, following local anesthetic administration, a full-thickness flap is elevated, facilitating access and visibility for a comprehensive assessment of the alveolar ridge and the specific site designated for implant placement. A closed sinus augmentation will be performed. Upon completion of the infracture of the sinus floor, L-PRF will be introduced into the osteotomy and precisely propelled into the sinus. Implants placement will follow placement of the L-PRF.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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
Exclusion Criteria
- •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
Arms & Interventions
Sinus Augmentation with Implant placement
Partially edentulous patients requiring maxillary sinus augmentation for dental implant placement
Intervention: Leukocyte Platelet Rich Fibrin (Biological)
Outcomes
Primary Outcomes
Maxillary Sinus Volume using 2D imaging
Time Frame: Baseline to 6 months
Regular x-rays are used to take measurements
Maxillary Sinus Volume using 3D imaging
Time Frame: Baseline to 6 months
3D CBCT images are used for measurements
Secondary Outcomes
No secondary outcomes reported