| CTRI Number |
CTRI/2025/11/097287 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of feracrylum and tranexamic acid to control bleeding in patients on anti platelet medication during tooth extraction. |
|
Scientific Title of Study
|
Efficacy of feracrylum and tranexamic acid as topical hemostatic agent in patients taking oral antiplatelets undergoing dental extraction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iniya Shree |
| Designation |
Post Graduate Student |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Meenakshi Ammal Dental College and Hospital Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9488627387 |
| Fax |
|
| Email |
driniyashree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pradeep Devadoss |
| Designation |
Professor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial, Surgery, Meenakshi Ammal Dental College and Hospital Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
98407 22457 |
| Fax |
|
| Email |
dr_pradeepds@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Iniya Shree |
| Designation |
Post Graduate Student |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Meenakshi Ammal Dental College and Hospital Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai
TAMIL NADU
600095
India |
| Phone |
9488627387 |
| Fax |
|
| Email |
driniyashree@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Iniya Shree |
| Address |
Meenakshi Ammal Dental College and Hospital Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai Chennai TAMIL NADU 600095 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Iniya Shree |
Meenakshi Ammal Dental College and Hospital |
Department of Oral and Maxillofacial surgery, Meenakshi Ammal Dental College and Hospital Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai Chennai TAMIL NADU 600095 India
Chennai
TAMIL NADU |
9488627387
driniyashree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicalCommittec,MeenakshiAmmalDentalColegeandHospital,Maduravoyal,Chennai-95. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: CARDIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tranexamic acid | Tranexamic acid, an artificial lysine analog, functions as an antifibrinolytic by competitively inhibiting plasminogen activation, hence preventing fibrin degradation and stabilizing clots. Patients exhibiting heightened fibrinolytic activity, as observed in those undergoing prolonged antiplatelet therapy, this biochemical mechanism is particularly beneficial. Topical use of tranexamic acid can yield safer outcomes for high-risk patients by effectively reducing intraoperative and postoperative bleeding without disrupting systemic fibrinolysis. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Feracrylum 1% solution, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(ml), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Topical application of Feracrylum 1% solution using sterile gauze in extraction socket for haemostasis; standard postoperative care given. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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 Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/12/2025 |
| Date of Study Completion (India) |
20/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Topical haemostatic agents are essential in controlling bleeding during tooth extractions. Common agents include oxidized regenerated cellulose, collagen-based products, fibrin sealants, and chitosan-based dressings, each promoting clot formation through different mechanisms. However, these traditional agents have limitations such as poor antimicrobial activity, longer application time, high cost, or hypersensitivity risks. Among newer options, Feracrylum and Tranexamic acid are particularly effective, especially for patients on antiplatelet therapy. Feracrylum, a synthetic polymer from polyacrylic acid, forms a bioadhesive gel that stabilizes clots and has antibacterial properties, reducing infection risk. It is non-toxic, biocompatible, and suitable for patients with systemic conditions like diabetes or hypertension. Tranexamic acid, a synthetic lysine analog, acts as an antifibrinolytic by preventing fibrin breakdown, thereby stabilizing the clot. It is highly beneficial for patients with increased fibrinolytic activity or systemic bleeding risk, offering effective local haemostasis without systemic side effects.
Both agents have shown proven efficacy in clinical studies, making them valuable choices for managing haemorrhage in dental extractions—Feracrylum for its combined antibacterial and haemostatic effects, and Tranexamic acid for its strong clot-stabilizing action. |