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Oral Surgery in Patients Taking Direct Oral Anticoagulants

Oral Surgery in Patients Taking Direct Oral Anticoagulants and Vitamin K Antagonists

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04505475
Acronym
OSDOA
Enrollment
82
Registered
2020-08-10
Start date
2015-05-25
Completion date
2020-08-03
Last updated
2020-08-13

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

Conditions

Anticoagulants and Bleeding Disorders, Dentoalveolar Haemorrhage, Postoperative Hemorrhage, Surgery

Keywords

oral anticoagulants, dabigatran, rivaroxaban, warfarin, oral surgery, hemorrhage

Brief summary

This study evaluates the incidence of postoperative bleeding after oral surgical procedures in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists.

Detailed description

Vitamin K antagonists (VKA) are widely used in long term prevention and treatment of thromboembolism. In the last few years direct oral anticoagulants (DOACs) are available for clinical use, mostly in prevention of stroke and systemic embolisms in patients with nonvalvular atrial fibrillation, and prevention and treatment of venous thrombosis. Numerous studies confirmed that minor oral surgical procedures in patients taking VKA with therapeutic (International Normalized Ratio) INR levels can be safely performed without therapy interruption if proper local haemostatic measures are applied. Similar recommendations were given for the dental treatment of patients taking DOACs, but there is a lack of clinical studies. The aim of this study is to assess the incidence of bleeding complications after oral surgery in patients who continue their DOACs or VKA medications.

Interventions

PROCEDUREOral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)

single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy

Sponsors

University of Novi Sad
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male and female patients over 18 years * Patients taking regularly direct anticoagulant therapy: dabigatran, rivaroxaban or apixaban (DOACs group) * Patients taking regularly acenocoumarol with INR 2.0-3.5 on the day of the surgery (VKA group) * Indication for oral surgical procedure * Signed informed consent

Exclusion criteria

* Liver or renal disease * Coagulopathy * Pregnant or breastfeeding women * Allergy to lidocaine * Patients who stopped taking their anticoagulant medication * Patients taking VKA with INR \<2.0 or \>3.5 on the day of the procedure

Design outcomes

Primary

MeasureTime frameDescription
Postoperative bleeding event7 daysBleeding that requires additional surgical procedure

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026