LED Application Following Dental Extraction in Patients Taking Direct Oral Anticoagulants.
NCT ID: NCT06971081
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2023-08-17
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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LED+ Haemostatic sponge
The experimental group will receive both LED light application and haemostatic sponge treatment
LED 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
Haemostatic sponge only
The active comparator group will receive only the haemostatic sponge
No interventions assigned to this group
Interventions
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LED 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
Eligibility Criteria
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Inclusion Criteria
* Listed for dental extraction at EDH
* Willing and able to provide consent
Exclusion Criteria
* Known allergy to tranexamic acid
* Pregnant or breastfeeding females
* Recent involvement in other research studies
18 Years
80 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Locations
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UCL
London, , United Kingdom
Countries
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Related Links
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Other Identifiers
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23/SC/0050
Identifier Type: -
Identifier Source: org_study_id
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