Periodontal DiseasesNCT06296498
Application of L-PRF in Periodontal Surgery
A study testing Leukocyte Platelet-rich fibrin in people with Periodontal Diseases, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Leukocyte Platelet-rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2023to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between age 18 and 89
- Patients needing open flap debridement procedures for periodontal disease in one or more teeth in the same arch bilaterally (split mouth)
- Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report
- Female patients to include non- pregnant women of child-bearing potential.
Who cannot join
- Patients who disclose that they will not be able to cooperate with the follow-up schedule.
- Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
- Pregnant women or women intending to become pregnant during the study period
- Smokers who smoke > 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: The Effect of Application of L-PRF in Periodontal Surgery on Clinical Parameters and Patient Related Outcome Measures: A Randomized, Controlled, Clinical Study.
The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception.
Read the detailed description
Randomization to one of two standard of care procedures:
- Test group: After gingival flap reflection and debridement of bone and root surfaces L-PRF will be applied to the alveolar bone, tooth roots, and gingival flap prior to suturing.
- Control group (Standard of care): Gingival flap reflection and debridement of bone and root surfaces, followed by suturing of the gingival flaps.
The study is a split-mouth design, randomized, prospective clinical trial. The protocol will randomize gingival quadrants in subjects to one of two standard of care procedures OFD or OFD + L-PRF. Patients needing periodontal surgery to correct periodontal disease will be enrolled. There will be two subject groups in this study. Each subject will be randomized to one of the treatments for the first quadrant and the contralateral quadrant will receive the other treatment. No risk is expected from being assigned to either group as both procedures are standard of care, with possible benefit of enhanced wound healing and bone regeneration in the test group.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
- Conditions
- Periodontal Diseases
- Being tested
- Leukocyte Platelet-rich fibrin, Standard of care OFD
- Keywords
- Open flap debridement, Periodontal surgery, Periodontal wound healing
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte Platelet-rich fibrinProcedure or surgery
Also called L-PRF
Leukocyte-PRF (L-PRF) contains neutrophils and macrophages that facilitate bacteria and necrotic tissue elimination via phagocytosis
Standard of care OFDOther
Also called Open Flap Debridement
Open flap debridement (OFD) is one periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone.
| Study group | Role | What they receive |
|---|---|---|
| Group OFD + L-PRF | Active comparator | Open flap debridement (OFD) with L-PRF is used during periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone. Receives: Procedure: Leukocyte Platelet-rich fibrin |
| Group OFD | Other | Open flap debridement (OFD) is one periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone. Receives: Other: Standard of care OFD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Depth of gingival pocket
Measured: 3 months and 6 months
Postoperative Pain (PROM)
Change in Patient reported outcome measures measured by a 10 point scale with 0 being no pain and 10 is the worst pain ever experienced.
Measured: 12 to 168 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start19 Aug 2023
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a split-mouth design, randomized, prospective clinical trial in which we will use either OFD alone or OFD + L-PRF for periodontal surgery. Both procedures are standard of care
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Powell, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296498
- Sponsor's protocol ID
- 20230505HU
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified participant data will be shared with colleagues
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Application of L-PRF in Periodontal Surgery on Clinical Parameters and Patient Related Outcome Measures: A Randomized, Controlled, Clinical Study.
- ClinicalTrials.gov ID
- NCT06296498
- Acronym / sponsor ID
- 20230505HU
- Conditions
- Periodontal Diseases
- Keywords
- Open flap debridement, Periodontal surgery, Periodontal wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 19 Aug 2023 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 6 Mar 2024 (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.
The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception.
Detailed description
Randomization to one of two standard of care procedures:
- Test group: After gingival flap reflection and debridement of bone and root surfaces L-PRF will be applied to the alveolar bone, tooth roots, and gingival flap prior to suturing.
- Control group (Standard of care): Gingival flap reflection and debridement of bone and root surfaces, followed by suturing of the gingival flaps.
The study is a split-mouth design, randomized, prospective clinical trial. The protocol will randomize gingival quadrants in subjects to one of two standard of care procedures OFD or OFD + L-PRF. Patients needing periodontal surgery to correct periodontal disease will be enrolled. There will be two subject groups in this study. Each subject will be randomized to one of the treatments for the first quadrant and the contralateral quadrant will receive the other treatment. No risk is expected from being assigned to either group as both procedures are standard of care, with possible benefit of enhanced wound healing and bone regeneration in the test group.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The proposed study is a split-mouth design, randomized, prospective clinical trial in which we will use either OFD alone or OFD + L-PRF for periodontal surgery. Both procedures are standard of care
| Arm | Type | Receives |
|---|---|---|
| Group OFD + L-PRF | Active comparator | Procedure: Leukocyte Platelet-rich fibrinOpen flap debridement (OFD) with L-PRF is used during periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone. |
| Group OFD | Other | Other: Standard of care OFDOpen flap debridement (OFD) is one periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between age 18 and 89
- Patients needing open flap debridement procedures for periodontal disease in one or more teeth in the same arch bilaterally (split mouth)
- Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report
- Female patients to include non- pregnant women of child-bearing potential.
Key exclusion criteria (4 listed)
- Patients who disclose that they will not be able to cooperate with the follow-up schedule.
- Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
- Pregnant women or women intending to become pregnant during the study period
- Smokers who smoke > 10 cigarettes per day
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-PRFLeukocyte-PRF (L-PRF) contains neutrophils and macrophages that facilitate bacteria and necrotic tissue elimination via phagocytosis | Procedure or surgery | Group OFD + L-PRF |
| Standard of care OFDAlso: Open Flap DebridementOpen flap debridement (OFD) is one periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone. | Other | Group OFD |
Primary outcome
Probing depth
Time frame: 3 months and 6 months
Depth of gingival pocket
Postoperative Pain (PROM)
Time frame: 12 to 168 hours post surgery
Change in Patient reported outcome measures measured by a 10 point scale with 0 being no pain and 10 is the worst pain ever experienced.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. All deidentified participant data will be shared with colleagues
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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. This study is not recruiting at the moment.
Charles 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 study testing Leukocyte Platelet-rich fibrin in people with Periodontal Diseases, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: 3 months and 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 6 Jan 2026.