Platelet-rich fibrin ensures hemostasis after single tooth removal under factor Xa -inhibitors

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032456

Enrollment

Registered

2023-08-17

Start date

2022-08-22

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Factor Xa inhibitors, tooth extraction, intra- and postoperative bleeding, platelet-rich fibrin, hemostatic effect, hemostatic sponge

Interventions

Group 1: Single-tooth extraction was conducted under local anesthesia in n=21 patients using a split-mouth design (42 teeth). Using a double- blinded approach, the extraction socket on one side of the

bleeding which stopped after 1-hour gauze tamponade

bleeding which stopped after 1.5 hours of gauze tamponade. Patients were instructed to use pressure with gauze tamponades in domestic bleeding events. In cases of unstoppable bleeding, patients were a

Eligibility

Sex/Gender

All

Age

No minimum to 21 Years

Inclusion criteria

Inclusion criteria: Patients taking anti Factor Xa medications

Exclusion criteria

Exclusion criteria: Patienta with liver diseases, uncotrolled Diabetes, bleeding disorders, tumors, pregnancy.

Design outcomes

Primary

Measure	Time frame
In this clinical-prospective, randomized, double-blind study, single tooth extractions were performed at two contralateral sites of the same jaw using a split-mouth design in patients taking FXa inhibitors. Using a double-blind approach with simple randomization (using sealed envelopes), the extraction socket of the test group on one side of the jaw was filled with PRF and that of the control group on the other side of the jaw was filled with a hemostatic gelatin sponge (Hygitec, Aegis Lifesciences, Gujarat, India) . Ethical approval was obtained from the Ethics Committee of the Rhineland-Palatinate State Medical Association (Prot. No. 2021-16116 from May 3, 2022). The primary aim of the study: This prospective, double-blind, randomized, split-mouth study investigated the local hemostatic effect of autologous platelet-rich fibrin (PRF) inserted into the extraction socket in patients receiving FXa inhibitors (apixaban, rivaroxaban, edoxaban) should be compared with a hemostatic sponge as a therapeutic gold standard without the need to discontinue oral anticoagulant therapy.	—

Measure

Time frame

In this clinical-prospective, randomized, double-blind study, single tooth extractions were performed at two contralateral sites of the same jaw using a split-mouth design in patients taking FXa inhibitors. Using a double-blind approach with simple randomization (using sealed envelopes), the extraction socket of the test group on one side of the jaw was filled with PRF and that of the control group on the other side of the jaw was filled with a hemostatic gelatin sponge (Hygitec, Aegis Lifesciences, Gujarat, India) . Ethical approval was obtained from the Ethics Committee of the Rhineland-Palatinate State Medical Association (Prot. No. 2021-16116 from May 3, 2022). The primary aim of the study: This prospective, double-blind, randomized, split-mouth study investigated the local hemostatic effect of autologous platelet-rich fibrin (PRF) inserted into the extraction socket in patients receiving FXa inhibitors (apixaban, rivaroxaban, edoxaban) should be compared with a hemostatic sponge as a therapeutic gold standard without the need to discontinue oral anticoagulant therapy.

—

Secondary

Measure	Time frame
better healing of the operation field	—

Countries

Germany

Contacts

Public ContactPeer Kämmerer

Universitätsmedizin Mainz

peer.kaemmerer@unimedizin-mainz.de+49/6131/17 5086

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026