Health Condition 1: K010- Embedded teeth
Conditions
Interventions
Intervention1: Tranexamic acid (TXA) spray 10% w/v: Tranexamic acid (TXA) sprayed gauze applied topically with Pressure (Pressure will be applied by closing jaws) at tooth extraction site
Duration of therapy- 5 to 7 days
Control Intervention1: Placebo: Placebo sprayed gauze applied topically with Pressure (Pressure will be applied by closing jaws) at tooth extraction site
Duration of therapy- 5 to 7 days
Sponsors
Shilpa Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant females aged 18 years and above with a Body Mass Index (BMI) of at least 18.5 Kg/m2. 2. Subjects undergoing extraction of any 3rd molar teeth of four quadrants of the mouth. 3. All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits. 4. Extraction sites do not require primary closure or suturing 5. Subjects who are willing and able to take part and attend all required study visits, able to understand the information given to them and give written consent. 6. Along with normal subjects, subjects with control type diabetics (HbA1C levels less than 7) will be included in the study. 7. Along with normal subjects, subjects with controlled hypertension ( < 140/90mmHg) will be included in the study.
Exclusion criteria
Exclusion criteria: 1. Patients with personal and family history that could affect correct haemostasis. i.e subjects with Hemophilia conditions and Subjects with any clinically-significant coagulation disorder including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura. 2. Hb 3. Hypersensitivity to tranexamic acid and any of the ingredients 4. In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction 5. In patients with active intravascular clotting 6. Patients with thrombosis with concomitant use of Factor IX 7. Patients with history of visual disturbances. 8. Patients with history of epilepsy or seizures or convulsions 9. Scheduled to undergo a surgical procedure other than 3rd molar tooth extractions 10. Any abnormal findings during clinical or radiographic examination. Example: Patients with ankylosed or root morphological alterations that may complicate the procedure. 11. Patients with renal dysfunction /hepatic dysfunction. 12. Patients with uncontrolled diabetes (Haemoglobin A1c above 7.0%). 13. Patients with cardiovascular disorders such as Ischemic Heart Disease, Arrhythmias, Heart Failure and endocarditis 14. Patients with history hypertensive 140/90mmHg above. 15. Patients with history of uncontrolled thyroid abnormalities. 16. Patients who were transferred more than six hours after the trauma. 17. Immunosuppressive conditions such as AIDS, cancer or radiation therapies. 18. Pregnant/Lactating women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. 19. Patients who are undergoing bisphosphonate therapy 20. Subjects with positive COVID-19 results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to HemostasisTimepoint: At 3 min, 5 min, 10 min, 15 min, 20 min and 30 min application after tooth extraction | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications related to Tranexamic acid. To evaluate the general safety of the Test product compared to the placebo with occurrence of adverse events (AEs) at all the study visits.Timepoint: One week post-tooth extraction | — |
Countries
India
Contacts
Public ContactP Veerendra Kumar
Shilpa Medicare Limited
Outcome results
None listed