NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| DOAC Information about which type of DOAC and the dose that is prescribed to the patient will be collected. |
Procedure: Type of surgery
surgical or non-surgical extraction one or more teeth
Drug: Dabigatran
Drug: Rivaroxaban
Drug: Apixaban
Drug: Edoxaban
|
| Warfarin A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion. |
Procedure: Type of surgery
surgical or non-surgical extraction one or more teeth
Drug: Warfarin
|
| No blood thinners
|
Procedure: Type of surgery
surgical or non-surgical extraction one or more teeth
|
Outcome Measures
Primary Outcome Measures
- bleeding complication [4 weeks postoperatively]
proportion of patients who are in need of non planned/emergency medical or dental care after tooth extraction / oral surgery because of bleeding
Secondary Outcome Measures
- bleeding volume [the actual time of surgery]
the amount of blood that the patient is bleeding during tooth extraction / oral surgery
- surgical difficulty [the actual time of surgery]
estimation on a scale of 1-10 by the surgeon
- surgery time in minutes [the actual time of surgery]
- proportion of other postoperative complications [4 weeks postoperatively]
Eligibility Criteria
Criteria
Inclusion Criteria:
Need of dental extraction / oral surgery, and medication with:
-
warfarin or
-
DOACs or
-
no treatment or AK-platelet therapy and age-matched to group a) and b).
Exclusion Criteria:
Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skåne University Hospital | Helsingborg | Sweden | SE - 251 87 | |
| 2 | Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University | Malmö | Sweden | S-20506 |
Sponsors and Collaborators
- Malmö University
- Odontologisk Forskning i Region Skåne (OFRS)
Investigators
- Study Director: Jonas P becktor, DDS, PhD, Faculty of Odontology, Malmö University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AK-BLD