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| Name | Class |
|---|---|
| Region Skane | OTHER |
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Aims: To investigate the incidence of bleeding complications during oral surgical procedures in patients medicated with DOACs.
To investigate the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs.
To examine whether increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.
Previous studies have shown that the incidence of healthcare-consuming bleeding complications following oral surgical procedures in patients who are prescribed warfarin is approximately 4% (9). To investigate whether the incidence is higher or lower by the intake of DOAC it is considered to be sufficient with 100 patients in each group. The groups consist of patients who are prescribed warfarin, DOACs, as well as a control group.
Hypothetical outcomes: The incidence of bleeding complications and the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs are higher compared to patients medicated with warfarin and patients taking no anticoagulants. Increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.
Clinical relevance: The study will serve as a basis for the development of treatment guidelines for patients who medicate with DOACs. If it turns out that the oral surgery procedure presents no increased risk of complications and that the bleeding volume does not complicate the surgery significantly, it may be recommended that patients who medicate with DOACs whom are in need of oral surgical procedures seek ordinary dental care.
The continuous variables (amount of bleeding during surgery) will be analyzed with linear regression if they show normal distribution patterns.
The ordinal variables (postoperative bleeding complications) will be analyzed with ordinal logistic regression.
Dichotomous variables (presence of other postoperative complications) will be analyzed with logistic regression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOAC | Information about which type of DOAC and the dose that is prescribed to the patient will be collected. |
| |
| Warfarin | A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type of surgery | Procedure | surgical or non-surgical extraction one or more teeth |
|
| Measure | Description | Time Frame |
|---|---|---|
| bleeding complication | proportion of patients who are in need of non planned/emergency medical or dental care after tooth extraction / oral surgery because of bleeding | 4 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| bleeding volume | the amount of blood that the patient is bleeding during tooth extraction / oral surgery | the actual time of surgery |
| surgical difficulty | estimation on a scale of 1-10 by the surgeon |
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Inclusion Criteria:
Need of dental extraction / oral surgery, and medication with:
Exclusion Criteria:
Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse
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Patients referred to either the oral surgery department at Skåne University hospital or the department for Oral surgery and oral medicine, Malmö University.
The plan is to ask all patients consecutively referred to the clinics for participation.
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| Name | Affiliation | Role |
|---|---|---|
| Jonas P becktor, DDS, PhD | Faculty of Odontology, Malmö University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Helsingborg | SE - 251 87 | Sweden | |||
| Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40221663 | Derived | Johansson K, Becktor JP, Naimi-Akbar A, Svensson PJ, Gotrick B. Continuous use of direct oral anticoagulants during and after simple and surgical tooth extractions: a prospective clinical cohort study. BMC Oral Health. 2025 Apr 12;25(1):554. doi: 10.1186/s12903-025-05949-9. |
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| Dabigatran | Drug |
|
| Rivaroxaban | Drug |
|
| Apixaban | Drug |
|
| Edoxaban | Drug |
|
| Warfarin | Drug |
|
| the actual time of surgery |
| surgery time in minutes | the actual time of surgery |
| proportion of other postoperative complications | 4 weeks postoperatively |
| Malmö |
| S-20506 |
| Sweden |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| C552171 | edoxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
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