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CTRI Number  CTRI/2025/08/092524 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on intra and post operative bleeding Control after tooth removal in patients using blood thinners with Blue laser light, antifibrinolytic agent (Tranexamic Acid) and Chitosan dressing- An Invivo study. 
Scientific Title of Study   Comparison of post-extraction bleeding control in patients on dual antiplatelet therapy: A randomized controlled trial evaluating the efficacy of 470nm Blue laser, Tranexamic Acid and Chitosan. 
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 Talari Divya Sri 
Designation  I MDS 
Affiliation  Oral & Maxillofacial Surgery Department 
Address  Oral & Maxillofacial Surgery Department, Block-3, Vishnu Dental College, Vishnupur, West Godavari District, Andhra Pradesh, India.
Block-3, Vishnu Dental College, Vishnupur, Bhimavaram, Andhra Pradesh.
West Godavari
ANDHRA PRADESH
534202
India 
Phone  9703760763  
Fax  08816250894  
Email  divyasri.talari@vdc.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil B 
Designation  Reader 
Affiliation  Oral & Maxillofacial Surgery Department  
Address  Oral & Maxillofacial Surgery Department, Block-3, Vishnu Dental College.
Block-3, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari.
West Godavari
ANDHRA PRADESH
534202
India 
Phone  8142138848  
Fax  08816250894  
Email  anil@vdc.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anil B 
Designation  Reader 
Affiliation  Oral & Maxillofacial Surgery Department  
Address  Oral & Maxillofacial Surgery Department, Block-3, Vishnu Dental College.
Block-3, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari.
West Godavari
ANDHRA PRADESH
534202
India 
Phone  8142138848  
Fax  08816250894  
Email  anil@vdc.edu.in  
 
Source of Monetary or Material Support  
Vishnu Dental COllege, Vishnupur, bhimavaram-534202, West Godavari District, Andhra pradesh, India  
 
Primary Sponsor  
Name  Dr Talari Divya Sri 
Address  Oral & Maxillofacial Surgery Department, Block-3, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh, INDIA, 534202. 
Type of Sponsor  Other [self] 
 
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 Talari Divya Sri  Oral & Maxillofacial Surgery Department  Room No.2, PG Clinic, Block-3, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH 
9703760763
08816250894
divyasri.talari@vdc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Vishnu Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  470nm Blue Laser  Wavelength – 470 nm Average Power 0.8-1 W Continuous wave in non-contact Mode, Energy of 0.8 J For 30 Seconds, followed by second cycle if required based on the Haemostasis & sutured. Haemostatis agents. 
Intervention  Chitosan  Immediately after Extraction, Placement of Chitosan Wound Dressing will be done & sutured, By Axiostat company, Haemostatic agents. 
Comparator Agent  Conventional Procedure  Immediately after extraction, without placement of any material, suturing will be done. 
Intervention  Tranexamic Acid Gel Foam  Immediately after Extraction, Placement of Tranexamic Acid 100mg in 1ml injection with gel foam will be done & sutured, Haemostatic agents. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients aged 40-60 Years.
2.Patients on dual antiplatelet therapy
3.Patients requiring single molar tooth extraction
4.Patients willing to consent for the study.
 
 
ExclusionCriteria 
Details  1.Patient with INR more than 2.
2.Patients with Periapical pathology, requiring Trans alveolar extraction, Patients with Uncontrollable Blood Pressure greater than 140/90 mm of Hg and Diabetes Mellitus, Liver disease, Alcoholics, Smokers and Patients on Anticoagulants or on Other Allied Medications, Hemostasis Achieved more than 20 Minutes. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemostasis confirmed using Filter paper method & to measure the time for Hemostasis in each of the interventional groups.
 
Immediately after the extraction, for 8 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
Total amount of blood loss using Gravimetric method
Wound healing scale using Landrys healing index
Post-operative complications
Satisfaction – 5 point Likert scale
Post-operative Pain using VAS
Need for any hemostatic interventions
 
During treatment &follow up on postop day-7. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   18/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This study is a randomized, double blind, parallel group trial comparing the efficacy of 470nm blue laser, Tranexamic acid and Chitosan dressing controlling post - extraction bleeding in patients on DAPT (Dual antiplatelet drug therapy). Patients on DAPT requiring any tooth removal in the upper& lower molars are included in the study.  Haemostasis following a tooth extraction is essential to prevent excessive blood loss prevent further sequelae of complications. Tooth extraction in patients on antiplatelet drugs cause prolonged post-extraction bleeding.  Antiplatelet drugs are prescribed for heart disease/ stroke patients. Dual antiplatelet drug therapy (DAPT) refers to any combination of 2 different antiplatelet drugs. In literature, it is proved that simple extraction is considered as low bleeding risk procedure, which can be operated without interruption of DAPT in patients. Although there are established AHA/SCOTTISH/NICE guidelines provided- not to interrupt DAPT for simple extraction, still general physicians/cardiologists recommend to discontinue DAPT for simple extraction would lead to further increased risk of venous thromboembolic events in the patients. In this study there is no need for interruption of DAPT for simple extraction of any molars in the upper & lower jaws, with concurrent bleeding risk, henceforth we intervene with various bleeding control agents- chitosan, tranexamic acid&470nm blue light laser   for control of post operative bleeding & evaluating the efficacy of using above 3 mentioned interventions to control post operative bleeding is studied. Primary Outcome: To evaluate the control of post extraction bleeding in patients using DAPT following various haemostatic measures. Secondary: To compare the control of post-extraction bleeding using interventions with the patients discontinuing DAPT for 3-5 days as control. To compare the time to achieve haemostasis. To assess the total amount of blood loss after the extraction using the Gravimetric method.  To evaluate the incidence of any post-operative complications (such as haematoma, or wound infection, reactionary haemorrhage. Patient satisfaction using a 5-point Likert scale. Pain levels using Visual analogue scale. To compare the need for any additional haemostatic interventions. Patient will be subjected for extraction of single molar, As per the included group, specific interventions will be performed. Visual examination bleeding and will be confirmed using Filter paper method. In all the group’s Figure of 8 suturing will be done using 3-0 black silk sutures & evaluated for Hemostatis confirmed using Filter paper method &Time for Hemostasis. Total amount of blood loss using Gravimetric method, Wound healing scale using Landrys healing index, Post- operative complications, Satisfaction – 5 point Likert scale, Post-operative Pain using VAS & Need for any other hemostatic  interventional methods like bonewax, cautery etc..

 

 
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