RecruitingPhase 4ACTRN12615001009505

Safety of Dental Extraction on New Oral Anticoagulants (NOACs) withouT Stopping Therapy (DENTST study)

In patients having dental extractions, is continuing new oral anticoagulants (NOACs) as safe as continuing warfarin in terms of bleeding amount?


Sponsor

Dr Jennifer Curnow

Enrollment

400 participants

Start Date

Feb 10, 2016

Study Type

Interventional

Conditions

Summary

For patients on warfarin, the safety of having dental extractions while continuing to take the drug has been well established. Bleeding rates are not significantly different between patients who continue warfarin and those who temporarily discontinue warfarin for their dental extractions. Warfarin interruption for dental extractions has been associated with a 1% risk of blood clots, which can be fatal. International and local guidelines therefore recommend warfarin be continued for simple dental extractions. There are currently no published studies to guide the management of new oral anticoagulants (NOACs, i.e. dabigatran, rivaroxaban and apixaban) around dental extractions. We hypothesise that the amount of bleeding post-extraction will be similar between patients who continue NOACs and patients who continue warfarin. By providing evidence that NOAC therapy can be safely continued for dental extractions, we believe that fewer patients will be exposed to the undue risk of developing blood clots by unnecessary interruption of anticoagulant therapy.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Patients on blood thinners (anticoagulants) often worry about having a tooth pulled. This study looks at whether it is safe to have a simple dental extraction without stopping newer blood thinners (dabigatran, rivaroxaban, or apixaban). Research with the older blood thinner warfarin already shows it is safe to continue during a simple tooth extraction. This study aims to show the same for the newer medicines. You may be eligible if: - You are 18 years old or older - You need a simple or surgical dental extraction - You are taking dabigatran, rivaroxaban, apixaban, or warfarin at a therapeutic dose You may NOT be eligible if: - You are pregnant - You are on dual antiplatelet therapy - You have an inherited bleeding disorder - Your platelet count is very low (below 50) - You have severe kidney impairment on certain anticoagulants - You are having wisdom teeth (third molars) removed surgically Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Study participants will continue their NOAC during dental extractions. There is currently no standard of care and no practice guidelines regarding NOAC management around dental extractions. It is up t

Study participants will continue their NOAC during dental extractions. There is currently no standard of care and no practice guidelines regarding NOAC management around dental extractions. It is up to the individual dentist to decide whether to stop the NOAC or not.


Locations(1)

Westmead Hospital - Westmead

NSW, Australia

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ACTRN12615001009505


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