LED Application Following Dental Extraction in Patients Taking Direct Oral Anticoagulants.

Not Applicable

Active, not recruiting

• Conditions: Direct Oral Anticoagulants (DOACs)

• Registration Number: NCT06971081
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-17
• Study First Submitted: 2025-04-16
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UCL; 🇬🇧 London, United Kingdom