Assessing the incidence of bleeding after minor oral surgery in patients taking daily low-dose Aspirin: A single center randomized controlled trial.

**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.