Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.
NCT ID: NCT06365242
Last Updated: 2024-05-10
Study Results
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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COMPLETED
49 participants
OBSERVATIONAL
2020-07-23
2022-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DOACs treated patients
Patients treated with DOACs undergoing oral extractions
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* patients under pharmacological treatment with DOACs
* patients requiring at least one dental extraction
* patients willing to take part in the study and to sign informed consent
Exclusion Criteria
* patients treated with antiplatelet therapy or vitamin K antagonists
* patients presenting with an International Normalized Ratio (INR) \>3.0
* patients suffering from congenital or acquired coagulopathies (e.g. haemophilia, coagulation factors deficiency, von Willebrand disease, thrombocytopenia, cirrhosis)
18 Years
ALL
No
Sponsors
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University of Pisa
OTHER
Responsible Party
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Antonio Barone
Full Professor of Oral Surgery and Implantology, Principal Investigator
Principal Investigators
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Antonio Barone
Role: PRINCIPAL_INVESTIGATOR
University of Pisa
Locations
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U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, , Italy
Countries
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References
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Lee JY, Park SH, Kim DM, Ko KA, Park JY, Lee JS, Jung UW, Cha JK. Risk of post-operative bleeding after dentoalveolar surgery in patients taking anticoagulants: a cohort study using the common data model. Sci Rep. 2024 Apr 2;14(1):7787. doi: 10.1038/s41598-024-57881-7.
Darwish G. The Effect of Direct Oral Anticoagulant Therapy (DOACs) on oral surgical procedures: a systematic review. BMC Oral Health. 2023 Oct 11;23(1):743. doi: 10.1186/s12903-023-03427-8.
Lababidi E, Breik O, Savage J, Engelbrecht H, Kumar R, Crossley CW. Assessing an oral surgery specific protocol for patients on direct oral anticoagulants: a retrospective controlled cohort study. Int J Oral Maxillofac Surg. 2018 Jul;47(7):940-946. doi: 10.1016/j.ijom.2018.03.009. Epub 2018 Apr 10.
Cocero N, Basso M, Grosso S, Carossa S. Direct Oral Anticoagulants and Medical Comorbidities in Patients Needing Dental Extractions: Management of the Risk of Bleeding. J Oral Maxillofac Surg. 2019 Mar;77(3):463-470. doi: 10.1016/j.joms.2018.09.024. Epub 2018 Sep 26.
Hiroshi I, Natsuko SY, Yutaka I, Masayori S, Hiroyuki N, Hirohisa I. Frequency of hemorrhage after tooth extraction in patients treated with a direct oral anticoagulant: A multicenter cross-sectional study. PLoS One. 2022 Apr 7;17(4):e0266011. doi: 10.1371/journal.pone.0266011. eCollection 2022.
Patel JP, Woolcombe SA, Patel RK, Obisesan O, Roberts LN, Bryant C, Arya R. Managing direct oral anticoagulants in patients undergoing dentoalveolar surgery. Br Dent J. 2017 Feb 24;222(4):245-249. doi: 10.1038/sj.bdj.2017.165.
Cabbar F, Cabbar AT, Cosansu K, Cekirdekci EI. Effects of Direct Oral Anticoagulants on Quality of Life During Periprocedural Management for Dental Extractions. J Oral Maxillofac Surg. 2019 May;77(5):904-911. doi: 10.1016/j.joms.2018.11.032. Epub 2018 Dec 12.
Johnston S. An evidence summary of the management of patients taking direct oral anticoagulants (DOACs) undergoing dental surgery. Int J Oral Maxillofac Surg. 2016 May;45(5):618-30. doi: 10.1016/j.ijom.2015.12.010. Epub 2016 Jan 7.
Mauprivez C, Khonsari RH, Razouk O, Goudot P, Lesclous P, Descroix V. Management of dental extraction in patients undergoing anticoagulant oral direct treatment: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Nov;122(5):e146-e155. doi: 10.1016/j.oooo.2016.06.003. Epub 2016 Jun 22.
Other Identifiers
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DOACS1_2024
Identifier Type: -
Identifier Source: org_study_id
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