| CTRI Number |
CTRI/2025/07/091808 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effectiveness of feracrylum in controlling bleeding, preventing infection and promote healing during dental implants treatment in patients on blood thinners |
|
Scientific Title of Study
|
EFFICACY OF FERACRYLUM AS A LOCAL HEMOSTATIC, ANTISEPTIC AND HYGROSCOPIC AGENT IN PATIENTS ON ANTITHROMBOTIC THERAPY UNDERGOING DENTAL IMPLANT PROCEDURE: A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arihant Bathiya |
| Designation |
Postgraduate student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Room number 101, Department of Oral and Maxillofacial Surgery , First floor, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongari Waddhamna Road Hingna Dist Nagpur 441110
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09049123101 |
| Fax |
|
| Email |
arihantbathiya33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Mishra |
| Designation |
Professor, Depatment of Oral and Maxillofacial Surgery |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Room number 101, Department of Oral and Maxillofacial Surgery , First floor, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongari Waddhamna Road Hingna Dist Nagpur 441110
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9860665430 |
| Fax |
|
| Email |
akshaym21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arihant Bathiya |
| Designation |
Postgraduate student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Room number 101, Department of Oral and Maxillofacial Surgery , First floor, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongari Waddhamna Road Hingna Dist Nagpur 441110
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09049123101 |
| Fax |
|
| Email |
arihantbathiya33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongari Waddhamna Road
Hingna Dist Nagpur 441110
|
|
|
Primary Sponsor
|
| Name |
Dr Arihant Bathiya |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongari Waddhamna Road
Hingna Dist Nagpur 441110
|
| 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 |
| Dr Arihant Bathiya |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Room number 101, Department of Oral and Maxillofacial Surgery , First floor, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongari Waddhamna Road Hingna Dist Nagpur 441110
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA |
09049123101
arihantbathiya33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDKS DENTAL COLLEGE ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, (2) ICD-10 Condition: D683||Hemorrhagic disorder due to circulating anticoagulants, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% Feracrylum solution |
2 ml solution, single dose irrigation for 30 second during surgery |
| Comparator Agent |
Normal Saline |
2 ml solution, single dose irrigation for 30 second during surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA Grade I - III
Patients on antithrombotic therapy requiring dental implant procedure
Patients requiring 1-5 dental Implants
Patients willing to participate in the study with informed written consent
having obtained medical fitness from the physician
|
|
| ExclusionCriteria |
| Details |
Patients with recent history of myocardial infract, bypass surgery of heart within six months
Patients having INR (International normalized ratio) more than 3
Patients below age 18
Pregnant or lactating women
Patients not abiding to the study protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feracrylum is effective as a local hemostatic, antiseptic and hygroscopic agent in patients on antithrombotic therapy undergoing dental implant procedure |
2 minute 5 minute 30 minute 24 hours 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arihantbathiya33@gmail.com].
- For how long will this data be available start date provided 16-02-2027 and end date provided 16-02-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, single centre trial evaluating efficacy of feracrylum as a local hemostatic for 2min. 5min , 30 min and 24 hours, antiseptic for preoperatively and postoperatively, and hygroscopic at 7th day in patients on antithrombotic therapy undergoing dental implant procedure in 32 patients will be conducted in one centre in India. Primary outcome will be Feracrylum is effective as a local hemostatic, antiseptic and hygroscopic agent in patients on antithrombotic therapy undergoing dental implant procedure |