NCT07836725

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
24mo left

Started Jan 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Partially Edentulous Maxilla

Keywords

Dental implantMaxillary sinus augmentationL-PRF

Outcome Measures

Primary Outcomes (2)

  • Maxillary Sinus Volume using 2D imaging

    Regular x-rays are used to take measurements

    Baseline to 6 months

  • Maxillary Sinus Volume using 3D imaging

    3D CBCT images are used for measurements

    Baseline to 6 months

Study Arms (1)

Sinus Augmentation with Implant placement

EXPERIMENTAL

Partially edentulous patients requiring maxillary sinus augmentation for dental implant placement

Biological: Leukocyte Platelet Rich Fibrin

Interventions

Leukocyte Platelet Rich FibrinBIOLOGICAL

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
Sinus Augmentation with Implant placement

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Study Officials

  • Charles A Powell, DDS, MS

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles A Powell, DDS, MS

CONTACT

210-567-3598powellc2@uthscsa.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 23, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

At the end of the study, all study databases will be de-identified and archived at the Graduate Periodontics UT Health San Antonio.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After study completion when data analysis is complete and a publication is accepted by a peer review journal.

Locations

US(1)