NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications

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.

Conditions

• Surgery, Oral
• Hemorrhage
• Postoperative Complications
• Oral Surgical Procedures
• Anticoagulants Causing Adverse Effects in Therapeutic Use
• Anticoagulant-induced Bleeding

Interventions

PROCEDURE

Type of surgery

surgical or non-surgical extraction one or more teeth

DRUG

Dabigatran

DRUG

Rivaroxaban

DRUG

Apixaban

DRUG

Edoxaban

DRUG

Warfarin

Sponsors & Collaborators

• Odontologisk Forskning i Region Skåne (OFRS)

  collaborator UNKNOWN

• Malmö University

  lead OTHER

Principal Investigators

• Jonas P becktor, DDS, PhD · Faculty of Odontology, Malmö University

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-01

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• Sweden

Study Locations