Study to evaluate the efficacy and safety of Tranexamic acid spray 10% w/v comparing with placebo in patients undergoing dental extraction.
- Conditions
- Health Condition 1: K010- Embedded teeth
- Registration Number
- CTRI/2022/03/041099
- Lead Sponsor
- Shilpa Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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.
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 < 10 and Platelet count < 50,000
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method