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

NCT06971081 | Active Not Recruiting

• 1 other identifier: 23/SC/0050
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Direct Oral Anticoagulants (DOACs)

Outcome Measures

Primary Outcomes (2)

• Bleeding time

  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

  (Performed intraoperatively) Immediately after intervention (LED) or control (Local Haemostatic Measures) application until bleeding control is achieved (up to 30 minutes)

• Number of bleeding events

  number of bleeding events

  From the application of intervention (LED) or control up to 7 days post-operatively

Study Arms (2)

LED+ Haemostatic sponge

EXPERIMENTAL

The experimental group will receive both LED light application and haemostatic sponge treatment

Other: LED light

Haemostatic sponge only

NO INTERVENTION

The active comparator group will receive only the haemostatic sponge

Interventions

LED light OTHER

(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

LED+ Haemostatic sponge

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Taking DOACs (rivaroxaban, apixaban, edoxaban, or dabigatran)
• Listed for dental extraction at EDH
• Willing and able to provide consent

You may not qualify if:

• Using concomitant antithrombotic drugs
• Known allergy to tranexamic acid
• Pregnant or breastfeeding females
• Recent involvement in other research studies

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

UCL

London, United Kingdom

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 14, 2025
• Study Start: August 17, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

GB (1)