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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct oral anticoagulants | Patients taking dabigatran, ravaroxaban or apixaban |
| |
| Vitamin K antagonists | Patients taking acenocoumarol with therapeutic INR levels (2.0-3.5) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing) | Procedure | single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative bleeding event | Bleeding that requires additional surgical procedure | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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Study includes patients taking direct oral anticoagulants (DOACs) and patients taking vitamin K antagonists (VKA) who require oral surgical procedure. The groups will be matched with respect to oral surgical procedure i.e. operative trauma.
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| Name | Affiliation | Role |
|---|---|---|
| Branislav Bajkin, PhD | University of Novi Sad, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Clinic of Vojvodina | Novi Sad | Vojvodina | 21000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38580558 | Derived | Bajkin BV, Tadic AJ, Komsic JJ, Vuckovic BA. Risk of dentoalveolar surgery postoperative bleeding in patients taking direct oral anticoagulants and vitamin K antagonists: A prospective observational study. J Craniomaxillofac Surg. 2024 Jun;52(6):772-777. doi: 10.1016/j.jcms.2024.03.035. Epub 2024 Apr 1. |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |