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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662515
• Other study ID #: AK-BLD
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Malmö University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Need of dental extraction / oral surgery, and medication with:

1. warfarin or

2. DOACs or

3. 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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Type of surgery
surgical or non-surgical extraction one or more teeth

Drug:
• Dabigatran

• Rivaroxaban

• Apixaban

• Edoxaban

• Warfarin

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Helsingborg
Sweden	Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Malmö University	Odontologisk Forskning i Region Skåne (OFRS)

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	bleeding volume	the amount of blood that the patient is bleeding during tooth extraction / oral surgery	the actual time of surgery
Secondary	surgical difficulty	estimation on a scale of 1-10 by the surgeon	the actual time of surgery
Secondary	surgery time in minutes		the actual time of surgery
Secondary	proportion of other postoperative complications		4 weeks postoperatively