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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04662515
Enrollment
216
Registered
2020-12-10
Start date
2016-06-01
Completion date
2023-12-31
Last updated
2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

surgical or non-surgical extraction one or more teeth

DRUGDabigatran
DRUGRivaroxaban
DRUGApixaban
DRUGEdoxaban
DRUGWarfarin

Sponsors

Odontologisk Forskning i Region Skåne (OFRS)
CollaboratorUNKNOWN
Malmö University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
bleeding complication4 weeks postoperativelyproportion of patients who are in need of non planned/emergency medical or dental care after tooth extraction / oral surgery because of bleeding

Secondary

MeasureTime frameDescription
bleeding volumethe actual time of surgerythe amount of blood that the patient is bleeding during tooth extraction / oral surgery
surgical difficultythe actual time of surgeryestimation on a scale of 1-10 by the surgeon
surgery time in minutesthe actual time of surgery
proportion of other postoperative complications4 weeks postoperatively

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026