An interventional study of Tranexamic Acid-Modified L-PRF and Absorbable Gelatin Sponge in Patients Receiving Direct Oral Anticoagulants, sponsored by Cumhuriyet University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Cumhuriyet University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Participants received tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) in the randomly allocated extraction socket as the local hemostatic intervention.
Other: Tranexamic Acid-Modified L-PRF
Participants received an absorbable gelatin sponge in the randomly allocated extraction socket as the local hemostatic intervention.
Other: Absorbable Gelatin Sponge
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.
Participants received an absorbable gelatin sponge in the randomly allocated extraction socket as a local hemostatic intervention.
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.
Time frame: 7, 14, and 21 days after tooth extraction
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.
Time frame: 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.
Time frame: 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.
Time frame: 24, 48, and 72 hours after tooth extraction
Plan to share: No — Individual participant data will not be shared because no IPD sharing plan was established for this study.
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Cumhuriyet University