Patients Receiving Direct Oral AnticoagulantsNCT07830875
Effect of Tranexamic Acid-Modified Leukocyte- and Platelet-Rich Fibrin on Hemostasis and Wound Healing After Tooth Extraction in Patients Receiving Direct Oral Anticoagulants
A study testing Tranexamic Acid-Modified L-PRF and Absorbable Gelatin Sponge in people with Patients Receiving Direct Oral Anticoagulants, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This randomized split-mouth clinical study evaluated the effects of tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) on hemostasis, postoperative pain, and soft-tissue wound healing after tooth extraction in patients receiving direct oral anticoagulants (DOACs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Receiving Direct Oral Anticoagulants
- What is being tested?
- Tranexamic Acid-Modified L-PRF and Absorbable Gelatin Sponge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 5 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Receiving treatment with one of the specified direct oral anticoagulants (DOACs) for at least 2 months
- No known hypersensitivity to the study materials
- No diagnosis of malignant or premalignant lesions
- Indication for extraction of at least two non-adjacent teeth
Who cannot join
- Refusal to participate or inability/unwillingness to provide written informed consent
- History of hypersensitivity or allergy to local anesthetics
- Immunosuppression
- Acute infection in any tooth planned for extraction
- Treatment with antiresorptive medications
- Essential or congenital coagulation disorders
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- Severe cirrhosis
- Chronic kidney disease
- Uncompensated diabetes mellitus
- Uncontrolled hypertension
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University Faculty of Dentistry
Sivas, Sivas, 58000
About this study
Official title: Evaluation of the Effects of Local Application of Tranexamic Acid Combined With Leukocyte- and Platelet-Rich Fibrin on Hemostasis and Wound Healing After Tooth Extraction in Patients Receiving Direct Oral Anticoagulants
This randomized split-mouth clinical study evaluated the effects of tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) on hemostasis, postoperative pain, and soft-tissue wound healing after tooth extraction in patients receiving direct oral anticoagulants (DOACs). In each participant, extraction sites were allocated to either tranexamic acid-modified L-PRF or an absorbable gelatin sponge as a local hemostatic intervention. Hemostasis was assessed 30 minutes after extraction, postoperative pain was evaluated at 24, 48, and 72 hours, and soft-tissue wound healing was assessed on days 7, 14, and 21.
- Being tested
- Tranexamic Acid-Modified L-PRF, Absorbable Gelatin Sponge
- Keywords
- Direct Oral Anticoagulants, Tooth Extraction, Tranexamic Acid, Leukocyte- and Platelet-Rich Fibrin, Hemostasis, Landry Wound Healing Index, Split-Mouth, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid-Modified L-PRFOther
Participants received tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) in the randomly allocated extraction socket. L-PRF was prepared from 8 mL of venous blood with the addition of 0.4 mL tranexamic acid (250 mg/5 mL) before centrifugation at 2700 rpm for 12 minutes. The resulting TXA-modified L-PRF was placed into the extraction socket as a local hemostatic intervention.
Absorbable Gelatin SpongeOther
Participants received an absorbable gelatin sponge in the randomly allocated extraction socket as a local hemostatic intervention.
| Study group | Role | What they receive |
|---|---|---|
| TXA-Modified L-PRF | Experimental | Participants received tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) in the randomly allocated extraction socket as the local hemostatic intervention. Receives: Other: Tranexamic Acid-Modified L-PRF |
| Absorbable Gelatin Sponge | Active comparator | Participants received an absorbable gelatin sponge in the randomly allocated extraction socket as the local hemostatic intervention. Receives: Other: Absorbable Gelatin Sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue wound healing assessed using the Landry Wound Healing Index
Soft tissue wound healing was assessed by a blinded examiner using the Landry Wound Healing Index. The index evaluates tissue color, suppuration, bleeding, granulation tissue, and connective tissue exposure. Healing was scored on a 1-5 scale: 1 = very poor, 2 = poor, 3 = good, 4 = very good, and 5 = excellent healing. Higher scores indicate better soft tissue healing.
Measured: 7, 14, and 21 days after tooth extraction
Secondary outcomes (3)
Postoperative hemostasis at 30 minutes
Postoperative bleeding was assessed by a blinded examiner 30 minutes after placement of the final suture using a 0-5 clinical bleeding scale: 0 = no bleeding; 1 = minimal bleeding that stopped spontaneously; 2 = moderate bleeding controlled with simple pressure; 3 = marked bleeding potentially requiring medical intervention; 4 = uncontrolled bleeding potentially requiring serious medical intervention; and 5 = excessive, potentially life-threatening bleeding. Higher scores indicate greater bleeding severity.
Measured: 30 minutes after placement of the final suture
Postoperative pain assessed using the Visual Analog Scale
Postoperative pain was assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Participants recorded pain intensity separately for the TXA-modified L-PRF and absorbable gelatin sponge extraction sites. Higher scores indicate greater pain intensity.
Measured: 24, 48, and 72 hours after tooth extraction
Postoperative analgesic consumption
Postoperative analgesic consumption was assessed by recording the number of analgesic tablets taken for pain associated with each extraction site. Participants recorded analgesic use separately for the TXA-modified L-PRF and absorbable gelatin sponge sites. A higher number of tablets indicates greater analgesic consumption.
Measured: 24, 48, and 72 hours after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Aug 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Receiving Direct Oral AnticoagulantsStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant received both interventions in a split-mouth design. Two non-adjacent extraction sites within the same participant were randomly allocated to either tranexamic acid-modified L-PRF or an absorbable gelatin sponge.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Yiğit, Cumhuriyet University
- Investigators
- Abdullah İ Özeç, PhD, Study director, Sivas Cumhuriyet University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830875
- Sponsor's protocol ID
- 2025-06/38
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no IPD sharing plan was established for this study.
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
- Evaluation of the Effects of Local Application of Tranexamic Acid Combined With Leukocyte- and Platelet-Rich Fibrin on Hemostasis and Wound Healing After Tooth Extraction in Patients Receiving Direct Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT07830875
- Acronym / sponsor ID
- 2025-06/38
- Keywords
- Direct Oral Anticoagulants, Tooth Extraction, Tranexamic Acid, Leukocyte- and Platelet-Rich Fibrin, Hemostasis, Landry Wound Healing Index, Split-Mouth, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 21 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.
This randomized split-mouth clinical study evaluated the effects of tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) on hemostasis, postoperative pain, and soft-tissue wound healing after tooth extraction in patients receiving direct oral anticoagulants (DOACs). In each participant, extraction sites were allocated to either tranexamic acid-modified L-PRF or an absorbable gelatin sponge as a local hemostatic intervention. Hemostasis was assessed 30 minutes after extraction, postoperative pain was evaluated at 24, 48, and 72 hours, and soft-tissue wound healing was assessed on days 7, 14, and 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant received both interventions in a split-mouth design. Two non-adjacent extraction sites within the same participant were randomly allocated to either tranexamic acid-modified L-PRF or an absorbable gelatin sponge.
| Arm | Type | Receives |
|---|---|---|
| TXA-Modified L-PRF | Experimental | Other: Tranexamic Acid-Modified L-PRFParticipants received tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) in the randomly allocated extraction socket as the local hemostatic intervention. |
| Absorbable Gelatin Sponge | Active comparator | Other: Absorbable Gelatin SpongeParticipants received an absorbable gelatin sponge in the randomly allocated extraction socket as the local hemostatic intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Receiving treatment with one of the specified direct oral anticoagulants (DOACs) for at least 2 months
- No known hypersensitivity to the study materials
- No diagnosis of malignant or premalignant lesions
- Indication for extraction of at least two non-adjacent teeth
Key exclusion criteria (11 listed)
- Refusal to participate or inability/unwillingness to provide written informed consent
- History of hypersensitivity or allergy to local anesthetics
- Immunosuppression
- Acute infection in any tooth planned for extraction
- Treatment with antiresorptive medications
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 |
|---|---|---|
| Tranexamic Acid-Modified L-PRFParticipants received tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) in the randomly allocated extraction socket. L-PRF was prepared from 8 mL of venous blood with the addition of 0.4 mL tranexamic acid (250 mg/5 mL) before centrifugation at 2700 rpm for 12 minutes. The resulting TXA-modified L-PRF was placed into the extraction socket as a local hemostatic intervention. | Other | TXA-Modified L-PRF |
| Absorbable Gelatin SpongeParticipants received an absorbable gelatin sponge in the randomly allocated extraction socket as a local hemostatic intervention. | Other | Absorbable Gelatin Sponge |
Primary outcome
Soft tissue wound healing assessed using the Landry Wound Healing Index
Time frame: 7, 14, and 21 days after tooth extraction
Soft tissue wound healing was assessed by a blinded examiner using the Landry Wound Healing Index. The index evaluates tissue color, suppuration, bleeding, granulation tissue, and connective tissue exposure. Healing was scored on a 1-5 scale: 1 = very poor, 2 = poor, 3 = good, 4 = very good, and 5 = excellent healing. Higher scores indicate better soft tissue healing.
3 secondary outcomes
Postoperative hemostasis at 30 minutes
Time frame: 30 minutes after placement of the final suture
Postoperative pain assessed using the Visual Analog Scale
Time frame: 24, 48, and 72 hours after tooth extraction
Postoperative analgesic consumption
Time frame: 24, 48, and 72 hours after tooth extraction
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 23 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no IPD sharing plan was established for this study.
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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.
Abdullah İ Özeç, PhD study director
Sivas Cumhuriyet University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid-Modified L-PRF and Absorbable Gelatin Sponge in people with Patients Receiving Direct Oral Anticoagulants, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 11 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 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 Turkey (Türkiye). 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?
Soft tissue wound healing assessed using the Landry Wound Healing Index (time frame: 7, 14, and 21 days after tooth extraction). 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.