| 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
|
|
|
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
|
|
|
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 :  Ethical clearance will be obtained from Institutional Ethical Review Board.  The study will be explained to the subjects and an informed consent for the study will be obtained from them. |
 The written consent will be obtained from their respective physician.  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.  For all the patients of Group A and Group B preoperative bleeding time, clotting time , prothrombin time , and platelet count will be recorded.  Those patients in which these parameters were in normal range will be included in study.  All the participants in Group A will continue their antiplatelet drug therapy prior to extraction.  All the participants in group B discontinued antiplatelet therapy 4 days prior to extraction.  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].  For every patient postoperative bleeding will be assessed after 30 minutes, 1 hour and 24 hours.  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.  If bleeding is present fresh pressure pack is reapplied for another 30 minutes and bleeding will be evaluated after that.  If after 1 hour bleeding is noted it will be controlled with the help of hemostatic methods, agents or diathermy.  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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