Oral Surgery in Patients Taking Direct Oral Anticoagulants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-25

Study Completion Date

2020-08-03

Brief Summary

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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.

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Detailed Description

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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

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Anticoagulants and Bleeding Disorders Surgery Postoperative Hemorrhage Dentoalveolar Haemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Direct oral anticoagulants

Patients taking dabigatran, ravaroxaban or apixaban

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

Intervention Type PROCEDURE

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

Vitamin K antagonists

Patients taking acenocoumarol with therapeutic INR levels (2.0-3.5)

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No