type of surgery
Proceduresurgical or non-surgical extraction one or more teeth
NCT Number: NCT04662515
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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Observational
Skåne University Hospital, Helsingborg, Sweden
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.
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:
Exclusion criteria
Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse
surgical or non-surgical extraction one or more teeth
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
Time frame: the actual time of surgery
the amount of blood that the patient is bleeding during tooth extraction / oral surgery
Time frame: the actual time of surgery
estimation on a scale of 1-10 by the surgeon
Time frame: the actual time of surgery
Time frame: 4 weeks postoperatively
Malmö University
Other
Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications
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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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