| 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
|
|
|
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
|
|
|
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.. |