Clinical trial NCT06365242: Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.
Official title: Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Hemorrhage
Keywords: Direct Oral Anticoagulants
oral Surgical Procedure
Post-operative complications
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients referred to the Unit of Dentistry and Oral Surgery for dental extraction between 2021 and 2023 were enrolled in this study. All the study participants signed an informed consent form to be included in the study.

Brief summary: Evaluation of DOACs treatment on post-extraction bleeding

Detailed description: Consecutive patients requiring at least one dental extraction were enrolled. DOACs regimen was either maintained or suspended. Patients were classified in subgroups depending on the number of teeth extracted per procedure (≤ 3 or \> 3), the need for flap raising and the performance of osteotomy. Bleeding was recorded intraoperatively, perioperatively at 20, 40, 60 and 80 minutes after the procedure, and in the first seven days post-operatively.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* 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 below 18 years of age
* 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)

Primary outcomes:
measure: Peri-operative hemorrhage
timeFrame: 20 minutes to 80 minutes
measure: Post-operative bleeding
timeFrame: day 1 to 7 post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale
Study officials:
affiliation: University of Pisa
name: Antonio Barone
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.