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CTRI Number  CTRI/2024/02/062261 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To understand the difference in bleeding after tooth removal in patients taking blood thinner medication (Aspirin 75 or 150mg) compared to those not taking the medication. 
Scientific Title of Study   Assessing the incidence of bleeding after minor oral surgery in patients taking daily low-dose Aspirin: A single center randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
saha.mehul@manipal.edu  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mehul Saha 
Designation  Senior Lecturer 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095371131  
Fax    
Email  saha.mehul@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mehul Saha 
Designation  Senior Lecturer 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal


KARNATAKA
576104
India 
Phone  8095371131  
Fax    
Email  saha.mehul@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Mehul Saha 
Designation  Senior Lecturer 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal


KARNATAKA
576104
India 
Phone  8095371131  
Fax    
Email  saha.mehul@manipal.edu  
 
Source of Monetary or Material Support  
Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Kasturba Medical College & Hospital, Manipal 
 
Primary Sponsor  
Name  Dr Mehul Saha 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mehul Saha  Kasturba Medical College & Hospital  Room 4, Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA 
8095371131

saha.mehul@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Continuing antiplatelet medication during single tooth extraction under local anaesthesia  Patients will be advised to continue antiplatelet medication at the time of single tooth extraction under local anaesthesia 
Comparator Agent  Withholding antiplatelet medication during single tooth extraction under local anaesthesia  Patients will be advised to withhold antiplatelet medication for 5 days prior to single tooth extraction under local anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who are on single therapy of daily low-dose Aspirin 75mg or 150mg.
2. Patients who are more than 18 years and fall in ASA I or well controlled ASA II category.
3. Patients who need to undergo single tooth extraction by closed method under local anaesthesia in an OPD setting.
4. Patients who live within 25 km radius of the hospital.
5. Patients who give written consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Patients who are less than 18 years and fall in uncontrolled ASA II, ASA III, ASA IV and ASA V category.
2. Patients who have undergone PTCA procedure within the last 1 year or had history of CVA or MI within the last 6 months.
3. Patients who are on dual anti-coagulant therapy such as along with clopidogrel, heparin, warfarin or any other new-age anti-coagulants and other medications such as birth control pills, hormone replacement therapy, NSAIDs that can interact with Aspirin.
4. Patients with history of bleeding disorders, alcoholism and pregnant patients.
5. Patients who have to undergo major oral surgical procedures such as multiple teeth extraction, transalveolar extraction, large, multi-site biopsies and all other procedures that warrant ward admission and OT care.
6. Patients who live beyond 25 km radius of the hospital. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the incidence of bleeding after minor oral surgery (single tooth extraction) in patients taking daily low-dose Aspirin 75 - 150mg during the procedure, at 24 hours and at 48 hours after the procedure.
2. To assess the incidence of bleeding after minor oral surgery (single tooth extraction) in patients who have stopped oral anti-platelets 5 days prior to procedure during the procedure, at 24 hours and at 48 hours after the procedure.  
1. To assess the incidence of bleeding after minor oral surgery (single tooth extraction) in patients taking daily low-dose Aspirin 75 - 150mg during the procedure, at 24 hours and at 48 hours after the procedure.
2. To assess the incidence of bleeding after minor oral surgery (single tooth extraction) in patients who have stopped oral anti-platelets 5 days prior to procedure during the procedure, at 24 hours and at 48 hours after the procedure.  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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 4 
Date of First Enrollment (India)   01/03/2024 
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="0"
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  

4.   Patients reporting to Department of Oral and Maxillofacial Surgery for minor oral surgical procedures (single tooth extraction by closed method), who are on daily low-dose Aspirin and fulfilling all other inclusion criteria will be selected for the study. Patients will be randomized into two groups by block randomization. The block randomization method will be sealed envelope technique (blocks of 4). The two groups will be: 1. Patients who will continue daily low-dose Aspirin at the time of procedure (75mg - 150mg) (Group 1 – test group), 2. Patients who will withhold Aspirin  for 5 days prior to procedure (Group 2 – standard of care). All patients’ age, gender, dose and duration of Aspirin intake, and medical condition for which Aspirin is taken will be recorded. Patients who fulfill all inclusion criteria will undergo tooth extraction by closed method as per protocol. The operator and the patient will not be blinded. Cautery machine and other hemostatic measures will be kept ready to manage any uncontrollable bleed intra-operatively. Local hemostatic measures will be taken for all patients uniformly in the form of placing Gelfoam, suturing the surgical site, placing pressure pack, and giving strict post-surgical instructions. The number and weight of gauze pieces (2 X 2 inch) to be used intra-operatively for each patient will be kept constant. Post-operatively, the blood-soaked gauze pieces will be weighed on an electronic weighing scale. The difference in weight    of gauze pieces will be quantified as intra-operative blood loss (in ml) for the patient. The amount of blood loss for each patient will be documented. All patients will be prescribed the same medications post-operatively consisting of antibiotics and analgesics (paracetamol/ tramadol), and serratiopeptidase if indicated. Patients who have stopped Aspirin will be asked to re-start Aspirin the day after tooth extraction. All Group 1 patients will be provided one bottle of Botroclot solution (samples present in the department), one vial of Tranexamic acid (5 ml) (funded by the investigator) and a packet of 6 gauze pieces (2 X 2 inch) (standard of care) to take home. They will be advised to place Botroclot-soaked gauze packs, tranexamic acid-soaked gauze packs and ice packs at the extraction site in case of any minor ooze at home (after telephonic consultation). However, in case of any severe bleeding, they will be strictly advised to report to our OPD or Emergency center (treatment will be funded and travel expense will be reimbursed). Patients will be called on telephone at 24 hours and 48 hours to enquire regarding the number of gauze pieces, Botroclot solution and Tranexamic acid used (if any) and recorded. All patients will be recalled on 7th post-operative day for suture removal (standard of care). The quality of healing after procedure will be evaluated by assessing the incidence of wound dehiscence/ dry socket/ infection. The outcome assessor will be blinded. Patients will be asked to return the Botroclot and Tranexamic acid vial if not opened.

 
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