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

NCT04662515 | Completed

• 1 other identifier: AK-BLD
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• bleeding volume

  the actual time of surgery

• surgical difficulty

  the actual time of surgery

• surgery time in minutes

  the actual time of surgery

• proportion of other postoperative complications

  4 weeks postoperatively

Study Arms (2)

DOAC

Information about which type of DOAC and the dose that is prescribed to the patient will be collected.

Procedure: Type of surgery; 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; Drug: Warfarin

Interventions

Type of surgery PROCEDURE

surgical or non-surgical extraction one or more teeth

DOAC; Warfarin

Dabigatran DRUG

DOAC

Rivaroxaban DRUG

DOAC

Apixaban DRUG

DOAC

Edoxaban DRUG

DOAC

Warfarin DRUG

Warfarin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse

Sponsors & Collaborators

• Malmö University: lead
• Odontologisk Forskning i Region Skåne (OFRS): collaborator

Study Sites (2)

Skåne University Hospital

Helsingborg, SE - 251 87, Sweden

Location

Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University

Malmo, S-20506, Sweden

Location

Related Publications (1)

• 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.

  PMID: 40221663 DERIVED

MeSH Terms

Conditions

Hemorrhage; Postoperative Complications

Interventions

Dabigatran; Rivaroxaban; apixaban; edoxaban; Warfarin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Jonas P becktor, DDS, PhD

  Faculty of Odontology, Malmö University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Krister Johansson. Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: June 1, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

SE (2)