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NCT Number: NCT04662515

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Skåne University Hospital, Helsingborg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse

Treatment and study plan

type of surgery

Procedure

surgical or non-surgical extraction one or more teeth

dabigatran

Drug

Rivaroxaban

Drug

Apixaban

Drug

Edoxaban

Drug

Warfarin

Drug

Primary outcomes

  1. bleeding complication

    Time frame: 4 weeks postoperatively

    proportion of patients who are in need of non planned/emergency medical or dental care after tooth extraction / oral surgery because of bleeding

Secondary outcomes

  1. bleeding volume

    Time frame: the actual time of surgery

    the amount of blood that the patient is bleeding during tooth extraction / oral surgery

  2. surgical difficulty

    Time frame: the actual time of surgery

    estimation on a scale of 1-10 by the surgeon

  3. surgery time in minutes

    Time frame: the actual time of surgery

  4. proportion of other postoperative complications

    Time frame: 4 weeks postoperatively

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Collaborators

  • Region Skane

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2020
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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