Evaluation of the Intra- and Post- Operative Bleeding After Periodontal Debridement in Direct Anticoagulant Patients (NOADB_db)

April 18, 2017 updated by: prof. Roberto Di Lenarda, University of Trieste

Evaluation of the Intra- and Post- Operative Bleeding After After Periodontal Debridement in Direct Oral Anticoagulation Patients: a Longitudinal Observational Cohort Study

Direct Oral Anticoagulants were recently approved for medical treatment of several condition such as, non valvular atrial fibrillation, deep venous thrombosis, and others, substituting sometimes the conventional oral anticoagulants. The aim of the present study is to observe the possible difference in intra-operative and post-operative bleeding events for periodontal debridement.

Study Overview

Status

Status

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

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

Many protocols of drug suspension for surgical procedure has been designed, since the introduction of anticoagulant or antiplatelet medications. Nowadays it is not certain if suspension could give more costs than benefits for the clinical procedure itself. With the recent development of the Direct Oral Anticoagulant it is still unclear whether these medications might bring more bleeding events in the intra-operative and post-operative phase after periodontal causal therapy, equal to, or more than Oral Anticoagulant Therapy. The purpose of this study is to assess the degree of intra- and post-operative bleeding complication between direct oral anticoagulant therapy patients and Oral Anticoagulant Therapy patients for periodontal debridement.

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.
Observational

Enrollment (Anticipated)

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.
128

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Trieste, Italy, 34100
        • Recruiting
        • Clinica Odontoiatrica e Stomatologica
        • Contact:
        • Sub-Investigator:
          • Gaetano Castronovo, Dr.

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiovascular patient assuming oral anticoagulant therapy (conventional or direct)

Description

Direct Oral Anticoagulant

Inclusion Criteria:

  1. Male and female patients at 20 or more years of age.
  2. Healthy patients (≤ American Society of Anesthesiologists 3).
  3. Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Dabigatran (PRADAXA), Rivaroxaban (XARELTO), Apixaban (ELIQUIS), Edoxaban (LIXIANA).
  4. Indication for extraction of a single tooth.
  5. No other contraindications for tooth extraction.
  6. Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl.
  7. Signed informed consent.

Exclusion Criteria:

  1. Smoke > 10 cigarettes per day.
  2. Assumption of any antiplatelet medication.
  3. Assumption of Heparin medication.
  4. Assumption of oral anticoagulant medications (Warfarin, Coumadin).
  5. Wash-out period after antiplatelet or Heparin medication at least 15 days.
  6. Assumption of food or drugs that may alter direct oral anticoagulant blood values.
  7. Uncontrolled Hypertension.
  8. Uncontrolled Diabetes
  9. Chronic Hepatitis and/or reduction of hepatic function
  10. Coagulopathy (in excess of defect)
  11. Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
  12. Head and neck radiotherapy (previous 10 years).
  13. Chemotherapy (previous 2 years).
  14. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial.
  15. Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism).
  16. Pregnant or breastfeeding women.
  17. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).

Oral Anticoagulant Therapy

Inclusion Criteria:

  1. Male and female patients at 20 or more years of age.
  2. General health status (< American society of anesthesiologist a 3).
  3. Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Warfarin (COUMADIN), acenocoumarol (SINTROM).
  4. Indication for extraction of a single tooth.
  5. No contraindications for tooth extraction.
  6. Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl.
  7. International Normalized Ratio measured within 7 days prior to the procedure should between 2.0 and 3.0.
  8. No diet changes within the week before blood sampling (avoiding interacting food)
  9. Signed informed consent.

Exclusion Criteria:

  1. Smoke > 10 cigarettes per day.
  2. Assumption of any antiplatelet medication.
  3. Assumption of any Heparin medication.
  4. Assumption of any direct oral anticoagulant medication.
  5. Uncontrolled Hypertension.
  6. Uncontrolled Diabetes.
  7. Chronic Hepatitis and/or reduction of hepatic function
  8. Coagulopathy (in excess of defect)
  9. Wash-out period after antiplatelet or Heparin medication at least 15 days.
  10. Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
  11. Assumption of food or drugs that may alter oral anticoagulant blood values.
  12. Head and neck radiotherapy (previous 10 years).
  13. Chemotherapy (previous 10 years).
  14. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial.
  15. Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism).
  16. Pregnant or breastfeeding women.
  17. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Direct Oral Anticoagulants
assuming Pradaxa or Eliquis or Apixaban or Xarelto; undergoing periodontal debridement
Procedure: periodontal debridement
with ultrasonic device supragingival and subgingival full-mouth debridement is provided
Other Names:
  • subgingival scaling
oral anticoagulant therapy
assuming Coumadin or Sintrom; undergoing periodontal debridement
Procedure: periodontal debridement
with ultrasonic device supragingival and subgingival full-mouth debridement is provided
Other Names:
  • subgingival scaling

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
intra-operative bleeding
Time Frame: 30 minutes
intra-operative bleeding is registered as follows: mild if stopped in 20 seconds; medium: if stopped after not more than one minute; severe: if not stopped.
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
post-operative bleeding events
Time Frame: 1 week
a questionnaire is given to the patient to register post-operative bleeding events
1 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
oral health status
Time Frame: 1 week before
examination of the oral cavity, registration of periodontal indices
1 week before
cardiological assessment
Time Frame: 1 week before
registration of the Atrial Fibrillation Stroke Risk score
1 week before
bleeding risk assessment
Time Frame: 1 week before
registration of the Score for Major Bleeding Risk score
1 week before

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 Trieste

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 Chair: Gaetano Castronovo, Dr., University of Trieste

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.

Helpful Links

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.
August 15, 2016

Primary Completion (Anticipated)

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 15, 2017

Study Completion (Anticipated)

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.
November 15, 2018

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).
March 30, 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.
April 18, 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.
April 21, 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.
April 21, 2017

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.
April 18, 2017

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.
April 1, 2017

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.
  • NOADB_debridement

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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