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CTRI Number  CTRI/2021/03/032465 [Registered on: 31/03/2021] Trial Registered Prospectively
Last Modified On: 30/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare the amount of bleeding with or without discontinuing blood thinners in patients who required teeth extraction. 
Scientific Title of Study   A comparative study to assess bleeding with or without discontinuing antiplatelet therapy in patients undergoing dental extraction. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr sanjay joshi 
Designation  Head of the department and professor 
Affiliation  HOD 
Address  terna dental college room no 131 department of oral and maxillofacial surgery Plot No 12 Sector 22 Opp Nerul West Railway Station Nerul West Navi Mumbai Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  9869057337  
Fax    
Email  sanjoshi99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr sanjay joshi 
Designation  Head of the department and professor 
Affiliation  HOD 
Address  terna dental college room no 131 department of oral and maxillofacial surgery Plot No 12 Sector 22 Opp Nerul West Railway Station Nerul West Navi Mumbai Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  9869057337  
Fax    
Email  sanjoshi99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrDimple k Chandra 
Designation  Head of the department and professor 
Affiliation   
Address  terna dental college room no 131 department of oral and maxillofacial surgery Plot No 12 Sector 22 Opp Nerul West Railway Station Nerul West Navi Mumbai Maharashtra 400706

Thane
MAHARASHTRA
400086
India 
Phone  9594960066  
Fax    
Email  dr.dimple10chandra@gmail.com  
 
Source of Monetary or Material Support  
From terna dental college 
 
Primary Sponsor  
Name  Dimple Chandra 
Address  terna dental college room no 131 department of oral and maxillofacial surgery Plot No 12 Sector 22 Opp Nerul West Railway Station Nerul West Navi Mumbai Maharashtra 400706 
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 
Drdimple chandra  Terna dental college   terna dental college room no 131 department of oral and maxillofacial surgery Plot No 12 Sector 22 Opp Nerul West Railway Station Nerul West Navi Mumbai Maharashtra 400706
Mumbai
MAHARASHTRA 
27721839

dr.dimple10chandra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Dental College Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I999||Unspecified disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individuals undergoing anti-platelet therapy who report to Department of Oral and Maxillofacial Surgery on daily OPD basis requiring extraction will be a part of the study.  Antiplatelet therapy will be continued before and after extraction. 
Comparator Agent  Individuals undergoing anti-platelet therapy who report to Department of Oral and Maxillofacial Surgery on daily OPD basis requiring extraction will be a part of the study.  Antiplatelet drugs will be discontinued 4 days before the extraction. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  . Patients on antiplatelet therapy requiring extraction.
2. Patients requiring single or multiple [up to 3] extractions.
3. Patients willing to participate in the study.
4. Patients on antiplatelet therapy for preventive prophylaxis. 
 
ExclusionCriteria 
Details  . Patients with hematological, renal, or liver disease.
2. Patients with bone marrow disorders or alcoholism.
3. Patients on any concurrent medication affecting hemostasis such as oral or
parental anticoagulants.
4. Patient on antiplatelet therapy as secondary prophylaxis
5. Pregnant and lactating women.
6. Patient with medical history which is an absolute contraindication for extraction. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intraoperative bleeding  30 minutes , 1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative duration of bleeding  24 hours 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/04/2021 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Antiplatelet drugs are used for the primary and secondary prevention of cardiovascular events and cerebrovascular disease, especially in patients with ischemic heart disease, a history of coronary artery bypass previous myocardial infarction, placement of a stent, non-hemorrhagic stroke, peripheral arterial disease, and transient ischemic attacks. The most commonly prescribed antiplatelet drugs are aspirin and clopidogrel, used as single therapy or in combination. Aspirin is non-steroidal anti-inflammatory drug that exhibits analgesic, antipyretic, anti-inflammatory properties. Its Mechanism of action involves an irreversible inhibition of cyclooxygenase, which is responsible for the conversion of arachidonic acid into prostaglandins, prostacyclin, and thromboxane. Evidence suggests that a 75–100 mg daily dose of aspirin is optimal for the long-term prevention of serious vascular events in high-risk patients. Clopidogrel is an antiplatelet drug causing irreversible inhibition of an adenosine diphosphate receptor (P2Y12) important in promoting platelet aggregation and cross-linking of platelets by fibrin. The dosage used is 75–100 mg/day, with a half-life of 8 h. Many patients receive a combination of antiplatelet drugs, e.g. aspirin and clopidogrel 4–6; this has been shown to have a synergistic antiplatelet action, with the risk of bleeding complications much greater for combined therapy than for single-drug therapy.

      The fear of uncontrolled or excessive bleeding has prompted dental practitioners to cease or alter the use of these drugs before extraction.  Several studies have demonstrated the risk of thrombosis and myocardial infarction after withdrawal of antiplatelet drugs.

PROCEDURE OF STUDY :
ï‚· Ethical clearance will be  obtained from Institutional Ethical Review Board.
ï‚· The study will be explained to the subjects and an informed consent for the
study will be obtained from them.


ï‚· The written consent will be obtained from their respective physician.
ï‚· The study population will be randomly divided into two groups:
o Group A
o Group B.
GROUP A: Antiplatelet therapy will be continued before and after extraction.
GROUP B: Antiplatelet drugs will be discontinued 4 days before the extraction
.
ï‚· For all the patients of Group A and Group B preoperative bleeding time, clotting
time , prothrombin time , and platelet count will be recorded.
ï‚· Those patients in which these parameters were in normal range will be included
in study.
ï‚· All the participants in Group A will continue their antiplatelet drug therapy prior
to extraction.
ï‚· All the participants in group B discontinued antiplatelet therapy 4 days prior to
extraction.
ï‚· Extractions will be performed with minimal trauma under local anesthesia (2%
lignocaine with vasoconstrictor).
 Intraoperative bleeding will be measured by “Guaze method” [2x2 inch surgical
gauze will be weighed pre and post operatively, and the difference in the weight
will be noted. Blood loss will be calculated based on the formula of 1gm = 1ml of
blood].
ï‚· For every patient postoperative bleeding will be assessed after 30 minutes, 1
hour and 24 hours.
ï‚· After the procedure, a gauze pressure pack will be applied to the extraction
socket for 30 minutes and bleeding will be evaluated clinically after 30 minutes.
ï‚· If bleeding is present fresh pressure pack is reapplied for another 30 minutes
and bleeding will be evaluated after that.
ï‚· If after 1 hour bleeding is noted it will be controlled with the help of hemostatic
methods, agents or diathermy.
ï‚· If after 24 hours bleeding is noted then patient will be hospitalized.


ï‚· All Patients will receive 500 mg of amoxycillin thrice a day and 500mg of
paracetamol for 3days.
ï‚· After the procedure, all the patients will be given a list of instruction about post
operative care and a telephone number to call the surgeon in case of
emergency.
ï‚· All the patients will be examined and questioned for bleeding at the
postoperative 24 hour follow-up.


 
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