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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 single dental extraction.
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 surgical 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 oral surgery procedure, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Oral Anticoagulants | assuming Pradaxa or Apixaban or Eliquis; undergo simple dental extraction |
| |
| Oral Anticoagulant therapy | assuming Coumadin or Sintrom; undergo simple dental extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simple dental extraction | Procedure | dental extraction is performed by an expert oral surgeon within 20 minutes. Non-resorbable suture are applied |
|
| Measure | Description | Time Frame |
|---|---|---|
| post-operative bleeding complication | questionnaire is provided to the patient for bleeding characterization | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| oral health status | examination of the oral cavity, registration of periodontal indices | 1 week before |
| cardiological assessment | registration of the Atrial Fibrillation Stroke Risk score |
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Direct Oral Anticoagulant
Inclusion Criteria:
Exclusion Criteria:
Oral Anticoagulant Therapy
Inclusion Criteria:
Exclusion Criteria:
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Cardiovascular patient assuming oral anticoagulant therapy (conventional or direct)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Di Lenarda, Prof | Contact | 0403992254 | 0039 | rdilenarda@units.it |
| Federico Berton, Dr. | Contact | 0403992020 | 0039 | fberton@units.it |
| Name | Affiliation | Role |
|---|---|---|
| Fulvia Costantinides, Dr. | University of Trieste | Study Chair |
| Federico Berton, Dr. | University of Trieste | Study Director |
| Roberto Di Lenarda, Prof. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Odontoiatrica e Stomatologica | Recruiting | Trieste | 34100 | Italy |
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| Label | URL |
|---|---|
| a discussion paper on clinical implications of oral anticoagulants | View source |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D001281 | Atrial Fibrillation |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| 1 week before |
| bleeding risk assessment | registration of the Score for Major Bleeding Risk score | 1 week before |
| intra-operative bleeding | a standardized cotton roll is weighted after imbibition on the post-extractive alveolus for 20 seconds | intra-operative |
| University of Trieste |
| Principal Investigator |
| Erika Visintini, Dr. | University of Trieste | Study Chair |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |