NCT04662515

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

Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 216 (actual)
• Sponsor: Malmö University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Type of surgery	surgical or non-surgical extraction one or more teeth
DRUG	Dabigatran
DRUG	Rivaroxaban
DRUG	Apixaban
DRUG	Edoxaban
DRUG	Warfarin

Timeline

• Start date: 2016-06-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-12-10
• Last updated: 2024-01-26

Locations

2 sites across 1 country: Sweden