| 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
|
|
|
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
|
|
|
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. |