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Not yet recruitingNCT07836725Updated Sep 23, 2026

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

An Early Phase 1 interventional study of Leukocyte Platelet Rich Fibrin in Partially Edentulous Maxilla, sponsored by The University of Texas Health Science Center at San Antonio. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by The University of Texas Health Science Center at San Antonio · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Partially Edentulous Maxilla

Keywords

  • Dental implant
  • Maxillary sinus augmentation
  • L-PRF
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Ability of participant to understand and the willingness to sign a written informed consent document.
  2. English speaking.
  3. Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c \< 7.0.
  4. Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement
  5. At minimum 5mm of native bone below the maxillary sinus inferior border

Exclusion criteria

Exclusion Criteria:

  1. Maxillary sinus disease
  2. Diabetes diagnosis with a current HbA1c > 7.1 or greater, or if HbA1c status cannot be confirmed, due to diabetes effect on bone metabolism
  3. Pregnant or attempting to become pregnant
  4. Having a disease that affects bone metabolism
  5. Use of medications known to affect bone metabolism
  6. Tobacco, cannabis or vaping use
  7. Alcoholism or other recreational drugs
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Sinus Augmentation with Implant placement

    Partially edentulous patients requiring maxillary sinus augmentation for dental implant placement

    Biological: Leukocyte Platelet Rich Fibrin

Interventions

  • BiologicalLeukocyte Platelet Rich Fibrin

    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

    Also known as: L-PRF

05

What researchers measure

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

06

Study locations

1 site
  • The University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
07

References and documents

Individual participant data

Plan to share: Yes — At the end of the study, all study databases will be de-identified and archived at the Graduate Periodontics UT Health San Antonio.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07836725
Lead sponsor
The University of Texas Health Science Center at San Antonio
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

Charles A Powell, DDS, MS
Contact
powellc2@uthscsa.edu
210-567-3598
Charles A Powell, DDS, MS
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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