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CTRI Number  CTRI/2025/05/087964 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of four different local bleeding controlling agents after extraction of tooth  
Scientific Title of Study   Comparative analysis of the efficacy of local hemostatic agents in minor oral surgical procedures A clinical study  
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 SAURABH MANOHAR DUDHE 
Designation  PG Student 
Affiliation  Jawahar medical foundation Annasaheb Chudaman Patil Memorial Dental College, Dhule 
Address  Room no 2, 1st floor, Jawahar medical foundation Annasaheb Chudaman Patil Memorial Dental College, Dhule Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  8378881683  
Fax    
Email  doctordudhe05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jay goyal 
Designation  PG guide 
Affiliation  Jawahar medical foundation Annasaheb Chudaman Patil Memorial Dental College, Dhule Dhule MAHARASHTRA 424001 India 
Address  room no 2, first floor Jawahar medical foundation Annasaheb Chudaman Patil Memorial Dental College, Dhule Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  8378881683  
Fax    
Email  jaygoyal1988@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SAURABH MANOHAR DUDHE 
Designation  PG Student 
Affiliation  Jawahar medical foundation Annasaheb Chudaman Patil Memorial Dental College, Dhule 
Address  Room no 2,first floor Jawahar medical foundation Annasaheb Chudaman Patil Memorial Dental College, Dhule Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  8378881683  
Fax    
Email  doctordudhe05@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral surgery, Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College Sakri Road, Morane Dhule 424001. Maharashtra, India 
 
Primary Sponsor  
Name  DR SAURABH MANOHAR DUDHE 
Address  Jawahar medical foundation Annasaheb Chudaman Patil Memorial Dental College, Dhule Dhule MAHARASHTRA 424001 India  
Type of Sponsor  Other [ [PG STUDENT] ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurabh Dudhe  awahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College  Department of Oral Surgery, Room no 2, Sakri Road, Morane, Dhule 424001,
Dhule
MAHARASHTRA 
8378881683

doctordudhe05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JAWAHAR MEDICAL FOUNDATIONS ANNASAHEB CHUDAMAN PATIL MEMORIAL DENTAL COLLEGE INSTITUTIONAL ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  adrenaline  Application of adrenaline as hemostatic agent on socket after tooth extraction for 15 mins 
Intervention  chitosan  Application of chitosan as hemostatic agent on socket after tooth extraction for 15 mins 
Intervention  Hemocoagulase   Application of hemocoagulase as hemostatic agent on socket after tooth extraction for 15 mins 
Comparator Agent  pressure gauze pack  Application of pressurized gauze pack on socket after tooth extraction 
Intervention  tranexamic acid   Application of tranexamic acid as hemostatic agent on socket after tooth extraction for 15 mins 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients giving voluntary consent for the study
Patient with no systemic disease will be taken
Patients undergoing extraction of tooth for any reason
Only upper or lower first and second molar will be taken
BT , CT count will be recorded prior to extraction on tooth and only normal range patients will be taken
 
 
ExclusionCriteria 
Details  Patients with any systemic disease or any psychiatric illness
Patients having blood disorders
Patients which may go for transalveolar extractions of tooth  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
estimation of bleeding time after different types of hemostatic application  once postoperatively and after one week 
 
Secondary Outcome  
Outcome  TimePoints 
comparative evaluation of efficacy of different hemostatic agents  once postoperatively & after one week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   10/06/2025 
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="0"
Months="1"
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 - NO
Brief Summary  

In oral surgery, both intraoperative and postoperative bleeding can pose significant risks to patients, potentially leading to severe complications if not properly controlled. It is essential for clinicians to be well-acquainted with the different hemostatic agents available and their appropriate use in various bleeding situations. Bleeding complications can occur in both healthy and medically compromised individuals. During oral surgical procedures, bleeding not only causes patient distress, pain, and discomfort but also interrupts the surgeon’s focus, resulting in frustration and prolonged procedure times. Tooth extraction is a common and invasive oral surgery performed in everyday dental practice, with post extraction bleeding being a frequent and acknowledged complication. Post extraction bleeding is defined as the presence of bleeding beyond the pressure pack. A variety of methods have been proposed to manage post extraction bleeding, applicable to both healthy and medically compromised patients. Management strategies can generally be divided into local and systemic approaches. Local interventions include the use of saline pressure packs, sutures, acrylic surgical splints, and local hemostatic agents. Local hemostatic agents used in oral surgery are divided into passive and active types. These include oxidized cellulose, resorbable gelatin sponges, collagen sponges, polysaccharide hemospheres, thrombin, cyanoacrylate glue, fibrin glue, antifibrinolytic mouthwashes like tranexamic acid, bone wax, ostene, calcium alginate, chitosan-based dressings, polysaccharide hemostats, tannic acid, and hemocoagulase. When necessary, systemic hemostatic agents can also be employed to help control bleeding. Unfortunately, many effective preventive and management strategies are underutilized due to insufficient knowledge about the coagulation process and the available materials and techniques. This study aims to assess the effectiveness of various chemical local hemostatic agents in controlling bleeding during oral surgical procedures.

 
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