Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.

Post Operative Hemorrhage Clinical Trial

— DOACS_1  

Official title:

Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06365242
• Other study ID #: DOACS1_2024
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: December 23, 2022

Study information

• Verified date: May 2024
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of DOACs treatment on post-extraction bleeding

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 23, 2022
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Post Operative Hemorrhage
• Postoperative Hemorrhage

Locations

Country	Name	City	State
Italy	U.O. Odontostomatologia e Chirurgia del Cavo Orale	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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 — View 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 — View 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. — View 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: 10.137 — View 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. — View 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: 1 — View 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/s4159 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-operative hemorrhage	Evaluation of early post-operative hemorrhage classified as absent, mild, oozing, moderate, and severe.	20 minutes to 80 minutes
Primary	Post-operative bleeding	Evaluation of post-operative bleeding classified as absent, mild, oozing, moderate, and severe.	day 1 to 7 post-operatively