NCT04505475

Oral Surgery in Patients Taking Direct Oral Anticoagulants

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: University of Novi Sad · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Oral 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

Timeline

• Start date: 2015-05-25
• Primary completion: 2020-08-03
• Completion: 2020-08-03
• First posted: 2020-08-10
• Last updated: 2020-08-13

Locations

1 site across 1 country: Serbia