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

June 11, 2022 updated by: Itamara Lucia Itagiba Neves, University of Sao Paulo General Hospital

Prospective Study of the Assessment of the Dental Protocol for Tooth Extraction in Patients With Atrial Fibrillation in Continuous Use of New Oral Anticoagulants: A Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403000
        • Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Clinical: Patients on concomitant use of antiplatelet agents or heparin, pregnant and lactating patients, with coagulation disorders, severe chronic renal insufficiency (CrCl <30), severe hepatopathies and proven to be allergic to lidocaine and / or epinephrine.
  • Dentistry: Odontophobic, edentulous, or healthy teeth; Deciduous teeth and Included teeth.
  • Regarding the time of medication intake: Regarding the time of medication intake Patients 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 intake schedule suggested by the attending physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rivaroxaban
As the rivaroxaban is ingested 1x/day, the interval between a maximum peak concentration and the other peak is 24 hours. Therefore, the surgery will be performed between two peaks of maximum drug concentration, knowing that the maximum peak concentration is an average of two hours after ingestion. So the surgical procedure should be scheduled 14 hours (2 hours+ 12 hours) after the last medication intake.
Drug: Rivaroxaban
Rivaroxaban 15 or 20mg tablet by mouth, every 24 hours, continuous use.
Other Names:
  • Xarelto
Experimental: Dabigatran and Apixaban
As dabigatran and apixaban are taken 2x/day, the interval between two peak concentration is 12 hours.Taking into account the first two hours of maximum peak concentration and half the interval between two peaks (2 hours + 6 hours = 8 hours), the surgical procedure must be programmed eight hours after the last intake of medication.
Drug: Dabigatran and Apixaban
Dabigatrana 110 or 150 mg tablet and Apixaban 2,5 or 5mg tablet by mouth, every 12 hours, continuous use.
Other Names:
  • Pradaxa and Eliquis
Active Comparator: Warfarin
The control group will consist of patients on chronic use of warfarin. The operation will be scheduled at any time, provided that the patient has INR value between 2.0 and 3.0 and test performed in maximum 15 days before surgery.
Drug: Warfarin
The dosage of Warfarin is individualized for each patient, according to the patient's TP/INR value. The value of TP/INR should be in the therapeutic dosage of 2.0 to 3.0
Other Names:
  • Marevan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A bleeding event (incidence of postoperative bleeding events)
Time Frame: 7 days
To evaluate the safety of a protocol regarding the risks of bleeding after dental extractions performed in patients with non-valvular atrial fibrillation in continuous use of the new oral anticoagulants, we compared the incidence of postoperative bleeding events after dental extractions between patients in use of new oral anticoagulants and those treated of warfarin without withdrawal of oral anticoagulant therapy.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Denise T Hachul, PhD, Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Principal Investigator: Itamara LI Neves, PhD, Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Study Chair: Elaine M Higashi, S, Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Study Chair: Ricardo S Neves, PhD, Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Study Chair: Francisco CC Darrieux, PhD, Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Study Chair: Mauricio I Scanavacca, PhD, Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Odonto-NOAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After thesis defense, the IPD will be available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo (http://www.teses.usp.br/index.php?option=com_jumi&fileid=12&Itemid=77&lang=ptbr), in a PDF file.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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