Direct Oral Anticoagulants (DOACs)
Conditions
Brief summary
The DENT-DOAC trial is a single-blinded RCT investigating the effectiveness of LED application following dental extractions in patients taking direct oral anticoagulants (DOACs) . The study aims to address a significant clinical challenge, as bleeding following dental extraction is a well-recognized complication in patients taking anticoagulants, and the number of patients taking DOACs requiring dental procedures has increased substantially in recent years. The trial will be conducted at the Eastman Dental Hospital (EDH-UCLH) and will recruit 50 participants who will be randomly divided into two groups of 25 each. The test group will receive both LED light application and haemostatic sponge treatment, while the control group will receive only the haemostatic sponge. The study population will include patients taking DOACs (rivaroxaban, apixaban, edoxaban, or dabigatran) and are scheduled for dental extraction. Exclusion criteria include patients using concomitant antithrombotic drugs, those with known allergy to tranexamic acid, pregnant or breastfeeding females, and those recently involved in other research studies. The trial's primary objective is to assess bleeding outcomes in these patients, with secondary objectives including evaluation of bleeding events (early/delayed; minor/moderate/severe) and analysis of associations between bleeding complications and various factors such as type of DOACs, surgical factors, and patient demographics. The statistical design has been carefully calculated to achieve 90% power to detect both a 50% difference in bleeding events and a 142-second difference in mean bleeding time between groups, with considerations made for a 10% drop-out rate. Patient follow-up will include immediate post-procedure assessment and telephone assessments on days 2 and 7 following the extraction.
Interventions
OTHERLED light
(Dental Light Cure), LED light at wavelengths of 420-480nm and will be applied for 30 seconds at a distance of 1cm from the extraction site
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Taking DOACs (rivaroxaban, apixaban, edoxaban, or dabigatran) * Listed for dental extraction at EDH * Willing and able to provide consent
Exclusion criteria
* Using concomitant antithrombotic drugs * Known allergy to tranexamic acid * Pregnant or breastfeeding females * Recent involvement in other research studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding time | (Performed intraoperatively) Immediately after intervention (LED) or control (Local Haemostatic Measures) application until bleeding control is achieved (up to 30 minutes) | Time to achieve bleeding control, measured in seconds or minutes, starting from the application of intervention (LED light) or control (standard local measures) until complete cession of visible bleeding at the site. Timing is recorded by a stopwatch |
| Number of bleeding events | From the application of intervention (LED) or control up to 7 days post-operatively | number of bleeding events |
Countries
United Kingdom
Outcome results
None listed