Partially Edentulous MaxillaEarly Phase 1NCT07836725
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
A Early Phase 1 study testing Leukocyte Platelet Rich Fibrin in people with Partially Edentulous Maxilla, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Partially Edentulous Maxilla
- What is being tested?
- Leukocyte Platelet Rich Fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Charles Powell, DDS, MS, 210-567-3539, powellc2@uthscsa.edu
About this study
Official title: Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin (L-PRF)
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.
- Conditions
- Partially Edentulous Maxilla
- Being tested
- Leukocyte Platelet Rich Fibrin
- Keywords
- Dental implant, Maxillary sinus augmentation, L-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte Platelet Rich FibrinBiological
Also called L-PRF
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
| Study group | Role | What they receive |
|---|---|---|
| Sinus Augmentation with Implant placement | Experimental | Partially edentulous patients requiring maxillary sinus augmentation for dental implant placement Receives: Biological: Leukocyte Platelet Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary Sinus Volume using 2D imaging
Regular x-rays are used to take measurements
Measured: Baseline to 6 months
Maxillary Sinus Volume using 3D imaging
3D CBCT images are used for measurements
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startJan 2027 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Edentulous MaxillaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles A Powell, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836725
- Sponsor's protocol ID
- STUDY00002807
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, all study databases will be de-identified and archived at the Graduate Periodontics UT Health San Antonio.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin (L-PRF)
- ClinicalTrials.gov ID
- NCT07836725
- Acronym / sponsor ID
- STUDY00002807
- Conditions
- Partially Edentulous Maxilla
- Keywords
- Dental implant, Maxillary sinus augmentation, L-PRF
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinus Augmentation with Implant placement | Experimental | Biological: Leukocyte Platelet Rich FibrinPartially edentulous patients requiring maxillary sinus augmentation for dental implant placement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukocyte Platelet Rich FibrinAlso: L-PRFL-PRF does not directly induce bone formation within the maxillary sinus; rather, it serves as an autologous biologic scaffold that facilitates the regenerative process | Biological | Sinus Augmentation with Implant placement |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. At the end of the study, all study databases will be de-identified and archived at the Graduate Periodontics UT Health San Antonio.
Related trials for Partially Edentulous Maxilla
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Active, not recruiting
Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Partially Edentulous Maxilla or Mandible
Active, not recruiting
Dimensional Changes in Single Crowns Supported by Short Transmucosal Implants With Diverging or Converging Neck Profiles in the Esthetic Zone
Edentulous Alveolar Ridge
Active, not recruiting
Fully Versus Partially Guided Implants Placement: Measurement of Accuracy of Implant Position and Passivity of Superstructures.
Completely Edentulous, Implant Assesment
Not yet recruiting
Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants
Partially Edentulous Maxilla, Partially Edentulous Mandible
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles A Powell, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Leukocyte Platelet Rich Fibrin in people with Partially Edentulous Maxilla, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles A Powell, DDS, MS (210-567-3598, powellc2@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary Sinus Volume using 2D imaging (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.