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NCT Number: NCT07836725

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location contact

Charles Powell, DDS, MS

CONTACT

[email protected]

210-567-3539

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 7.0.
  • 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

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

Treatment and study plan

Leukocyte Platelet Rich Fibrin

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

Other names: L-PRF

Primary outcomes

  1. Maxillary Sinus Volume using 2D imaging

    Time frame: Baseline to 6 months

    Regular x-rays are used to take measurements

  2. Maxillary Sinus Volume using 3D imaging

    Time frame: Baseline to 6 months

    3D CBCT images are used for measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Charles A Powell, DDS, MS

CONTACT

[email protected]

210-567-3598

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin (L-PRF)

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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