Tooth Extraction in Patients With Atrial Fibrillation in Use of New Oral Anticoagulants

Last updated: June 11, 2022
Sponsor: University of Sao Paulo General Hospital
Overall Status: Completed

Phase

3

Condition

Atrial Fibrillation

Chest Pain

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT03181386
Odonto-NOAC
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety of a protocol which does not suspend the new oral anticoagulants (dabigatran, rivaroxaban and apixaban) in front of dental extractions in patients with non-valvular atrial fibrillation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Selection of patients: Both genders, aged over 18 years, regardless of ethnicity,marital status, nationality, naturalness or profession, with non-valvular atrialfibrillation using dabigatran or rivaroxaban or apixaban or warfarin, under medicaloutpatient treatment or during the hospitalization period.
  • Dentistry: Patients with indications of exodontia of one to three permanent adjacentteeth erupted in the maxilla or mandible due to extensive dental caries or periodontaldisease.

Exclusion

Exclusion Criteria:

  • Clinical: Patients on concomitant use of antiplatelet agents or heparin, pregnant andlactating patients, with coagulation disorders, severe chronic renal insufficiency (CrCl <30), severe hepatopathies and proven to be allergic to lidocaine and / orepinephrine.
  • Dentistry: Odontophobic, edentulous, or healthy teeth; Deciduous teeth and Includedteeth.
  • Regarding the time of medication intake: Regarding the time of medication intakePatients taking rivaroxaban who routinely take the medication between 5:00 a.m. to 4:00 p.m. (unworkable schedule for surgery) that do not accept a change in the intakeschedule suggested by the attending physician.

Study Design

Total Participants: 60
Study Start date:
May 03, 2017
Estimated Completion Date:
February 01, 2022

Study Description

The sample will be divided into three groups according to the pharmacokinetics of the oral anticoagulant: rivaroxaban 1x/day (group 1); dabigatran and apixabana 2x/day (group 2) and warfarin (control group). Extraction of one to three teeth will be scheduled, in the valley of the new oral anticoagulants' concentration, considered the period of smallest haemorrhagic risk without suspension. In group 1 the surgery will be scheduled 14 hours after the last intake, in group 2 the surgery will be scheduled 8 hours after the last intake, while the control group will undergo the procedure with INR values between 2.0 and 3,0. Hemostatic measures with tranexamic acid paste intra alveolar, suture and biological glue GRF® (gelatin, resorcinol and formaldehyde) and post operative care will be associated. The patients will be contacted after the procedure to inform the presence or absence of late bleeding. The patient should return 24 hours later to evaluate the surgical site. This protocol is based on Guidelines and scientific articles, pharmacokinetics and clinical experience of the authors.

Connect with a study center

  • Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 05403000
    Brazil

    Site Not Available

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