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Comparison of feracrylum and tranexamic acid to control bleeding in patients on anti platelet medication during tooth extraction.

Efficacy of feracrylum and tranexamic acid as topical hemostatic agent in patients taking oral antiplatelets undergoing dental extraction - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097287
Enrollment
34
Registered
2025-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

None listed

Sponsors

Iniya Shree
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients eligible for this study were those aged 18 years or older who consented to participate in the trial. All participants were required to be on a regular regimen of low-dose aspirin (75-100 mg/day) or clopidogrel (75 mg/day) for primary prevention of cardiac complications. Additionally, the study focused on medically compromised patients who were deemed fit for simple extractions under local anaesthesia. Participants needed to have a bleeding time between 2 and 5 minutes, an Activated Partial Thromboplastin Time (APTT) of 30-40 seconds, and an International Normalized Ratio (INR) between 1.0 and 2.5, ensuring they had adequate blood coagulation parameters for safe surgical intervention. Finally, the study included patients who required simple tooth extractions, making them suitable candidates for the haemostatic treatments being evaluated.

Exclusion criteria

Exclusion criteria: Patients with the following conditions were excluded from the study to ensure the safety and validity of the results. Individuals under the age of 18 were excluded, as well as those who did not consent to participate. Patients who had an allergy to local anaesthetics or their constituents were also excluded, as this could interfere with the surgical procedure. Those with liver disease, or who were on combination antiplatelet drugs or NSAIDs that might interact with aspirin, were excluded due to the potential impact on bleeding risk and drug interactions. Additionally, patients with a history of serious haemorrhage following dental extractions were not included, as they might have an increased risk of complications. Patients who had discontinued antiplatelet medications prior to the procedure were also excluded. Other exclusion criteria included systemic conditions where tooth extraction is contraindicated, such as uncontrolled diabetes or hypertension, cancers like leukaemia or lymphoma, recent myocardial infarction or stroke (within the past 6 months), and blood disorders like haemophilia. Patients with end-stage renal disease, pregnant women in the 1st and 3rd trimesters, or those who had previously undergone radiation therapy in the extraction region were also excluded. These exclusions ensured that the study population was free from confounding factors that could compromise the outcomes or complicate the healing process.

Design outcomes

Primary

MeasureTime frame
Assessing the of efficacy of feracrylum and tranexamic acid as topical haemostatic agent in patients taking antiplatelets drugs undergoing dental extraction without stopping aspirin and clopidogrel.Timepoint: Assessing the of efficacy of feracrylum and tranexamic acid as topical haemostatic agent in patients taking antiplatelets drugs undergoing dental extraction without stopping aspirin and clopidogrel.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactIniya Shree

Meenakshi Ammal Dental College and Hospital

dr_pradeepds@yahoo.co.in98407 22457

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026