Direct Oral Anticoagulants (DOACs)DENT-DOACNCT06971081
LED Application Following Dental Extraction in Patients Taking Direct Oral Anticoagulants.
A study testing LED light in people with Direct Oral Anticoagulants (DOACs), run by University College, London at 1 site in United Kingdom.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Direct Oral Anticoagulants (DOACs)
- What is being tested?
- LED light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Aug 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Taking DOACs (rivaroxaban, apixaban, edoxaban, or dabigatran)
- Listed for dental extraction at EDH
- Willing and able to provide consent
Who cannot join
- Using concomitant antithrombotic drugs
- Known allergy to tranexamic acid
- Pregnant or breastfeeding females
- Recent involvement in other research studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blue-violet Light Emitting Diode Application Following Dental Extraction in Patients Taking Direct Oral Anticoagulants. A Randomised Controlled Clinical Trial
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.
Read more
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)
- Being tested
- LED light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED lightOther
(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
| Study group | Role | What they receive |
|---|---|---|
| LED+ Haemostatic sponge | Experimental | The experimental group will receive both LED light application and haemostatic sponge treatment Receives: Other: LED light |
| Haemostatic sponge only | No intervention | The active comparator group will receive only the haemostatic sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: (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
Measured: From the application of intervention (LED) or control up to 7 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start17 Aug 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Oral Anticoagulants (DOACs)Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971081
- Sponsor's protocol ID
- 23/SC/0050
- Acronym
- DENT-DOAC
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue-violet Light Emitting Diode Application Following Dental Extraction in Patients Taking Direct Oral Anticoagulants. A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06971081
- Acronym / sponsor ID
- DENT-DOAC / 23/SC/0050
- Conditions
- Direct Oral Anticoagulants (DOACs)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LED+ Haemostatic sponge | Experimental | Other: LED lightThe experimental group will receive both LED light application and haemostatic sponge treatment |
| Haemostatic sponge only | No intervention | –The active comparator group will receive only the haemostatic sponge |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Taking DOACs (rivaroxaban, apixaban, edoxaban, or dabigatran)
- Listed for dental extraction at EDH
- Willing and able to provide consent
Key exclusion criteria (4 listed)
- Using concomitant antithrombotic drugs
- Known allergy to tranexamic acid
- Pregnant or breastfeeding females
- Recent involvement in other research studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | LED+ Haemostatic sponge |
Primary outcome
Bleeding time
Time frame: (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
Time frame: From the application of intervention (LED) or control up to 7 days post-operatively
number of bleeding events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED light in people with Direct Oral Anticoagulants (DOACs), run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding time (time frame: (Performed intraoperatively) Immediately after intervention (LED) or control (Local Haemostatic Measures) application until bleeding control is achieved (up to 30 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.