DENT-DOAC
Research type
Research Study
Full title
Blue-violet Light Emitting Diode Application Following Dental Extraction in Patients Taking Direct Oral Anticoagulants. A Randomised Controlled Clinical Trial.
IRAS ID
313010
Contact name
Rachel Leeson
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
UCL Data Protection , Z6364106/2022/07/101
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
One of the artificial sources of blue-violet light is light emitting diode (LED). In dentistry, LED is used to for hardening white dental filling through photo-polymerisation. In addition to the photo-polymerisation capability, LED recently showed promising results in controlling bleeding after dental extraction by photo-coagulation.Direct oral anticoagulants are a newer generations of blood thinning drugs that are used to prevent stroke in patients with increased risk due to heart conditions. Since the first approval in 2018, DOACs have emerged as leading therapeutic alternatives to warfarin. DOACs provide both clinicians and patients with more effective, safe, and convenient treatment options. In the NHS, the prescription of DOACs increased from 9% of all anticoagulants in 2014 to 74% in 2019.
Despite DOACs becoming more popular and rapidly replacing warfarin, the dental literature is still lacking evidence-based recommendations on their management. The existing limited evidence supporting the use of LED to control bleeding after teeth removal encompasses few clinical trials on healthy patients or patients taking warfarin. Therefore, the aim of this study is to assess the effectiveness of LED as an adjunct to the standard local measures (haemostatic sponge) to control the bleeding after dental extraction in patients taking DOACs.
As with studies involving patients, this study will need ethical approval. Patients in this trial will be those taking DOACs and attending the Eastman Dental Hospital (EDH)for tooth removal. It recruit 50 participants. Potential participants will be assessed for eligibility and consented to participate in a randomised clinical trial. Following consent participants will be randomly allocated into the test group (LED+ haemostatic sponge) or control group (haemostatic sponge only) aiming for a parallel group design. After the dental surgery, bleeding time will be measured and recorded. Participants will be contacted by telephone on day 2 and day 7 to assess the bleeding outcomes.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0050
Date of REC Opinion
20 Feb 2023
REC opinion
Favourable Opinion