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?

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001009505

Acronym

DENTST

Enrollment

118

Registered

2015-09-28

Start date

2016-02-10

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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 to the individual dentist to decide whether to stop the NOAC or not.

Study design

Allocation

Non-randomised trial

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Requires simple or surgical dental extraction(s). 2. On therapeutic dose of dabigatran, rivaroxaban, apixaban or warfarin. 3. Able to give informed consent. 4. Age 18 or above.

Exclusion criteria

1. Women who are pregnant. 2. Concomitant use of dual anti-platelet therapy. 3. Inherited disorder of haemostasis. 4. Platelet count < 50 x 10^9/L. 5. Procedure for which operator requires OAC interruption. 6. OAC already ceased prior to procedure. 7. Patient on warfarin and INR < 2 or > 4. 8. Severe active oral infection associated with facial swelling. 9. Cockroft-Gaultcreatinine clearance < 25 ml/min for patients on dabigatran, < 30 ml/min for patients on rivaroxaban or apixaban. 11. Surgical extraction of wisdom teeth.

Outcome results