| 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
|
|
|
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
|
|
|
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
|
|
|
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. |