Clinical trial NCT06971081: LED Application Following Dental Extraction in Patients Taking Direct Oral Anticoagulants.
Official title: Blue-violet Light Emitting Diode Application Following Dental Extraction in Patients Taking Direct Oral Anticoagulants. A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Direct Oral Anticoagulants (DOACs)
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bleeding time
timeFrame: (Performed intraoperatively) Immediately after intervention (LED) or control (Local Haemostatic Measures) application until bleeding control is achieved (up to 30 minutes)
measure: Number of bleeding events
timeFrame: From the application of intervention (LED) or control up to 7 days post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL
Study officials:
References: