Comparison of post-extraction bleeding control in patients on dual antiplatelet therapy: A randomized controlled trial evaluating the efficacy of 470nm Blue laser, Tranexamic Acid and Chitosan.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Hemostasis confirmed using Filter paper method & to measure the time for Hemostasis in each of the interventional groups.
研究概览
简要总结
This study is a randomized, double blind, parallel group trial comparing the efficacy of 470nm blue laser, Tranexamic acid and Chitosan dressing controlling post - extraction bleeding in patients on DAPT (Dual antiplatelet drug therapy). Patients on DAPT requiring any tooth removal in the upper& lower molars are included in the study. Haemostasis following a tooth extraction is essential to prevent excessive blood loss prevent further sequelae of complications. Tooth extraction in patients on antiplatelet drugs cause prolonged post-extraction bleeding. Antiplatelet drugs are prescribed for heart disease/ stroke patients. Dual antiplatelet drug therapy (DAPT) refers to any combination of 2 different antiplatelet drugs. In literature, it is proved that simple extraction is considered as low bleeding risk procedure, which can be operated without interruption of DAPT in patients. Although there are established AHA/SCOTTISH/NICE guidelines provided- not to interrupt DAPT for simple extraction, still general physicians/cardiologists recommend to discontinue DAPT for simple extraction would lead to further increased risk of venous thromboembolic events in the patients. In this study there is no needfor interruption of DAPT for simple extraction of any molars in the upper & lower jaws, with concurrent bleeding risk, henceforth we intervene with various bleeding control agents- chitosan, tranexamic acid&470nm blue light laser for control of post operative bleeding & evaluating the efficacy of using above 3 mentioned interventions to control post operative bleeding is studied. Primary Outcome: To evaluate the control of post extraction bleeding in patients using DAPT following various haemostatic measures. Secondary: To compare the control of post-extraction bleeding using interventions with the patients discontinuing DAPT for 3-5 days as control. To compare the time to achieve haemostasis. To assess the total amount of blood loss after the extraction using the Gravimetric method. To evaluate the incidence of any post-operative complications (such as haematoma, or wound infection, reactionary haemorrhage. Patient satisfaction using a 5-point Likert scale. Pain levels using Visual analogue scale. To compare the need for any additional haemostatic interventions. Patient will be subjected for extraction of single molar, As per the included group, specific interventions will be performed. Visual examination bleeding and will be confirmed using Filter paper method. In all the group’s Figure of 8 suturing will be done using 3-0 black silk sutures & evaluated for Hemostatis confirmed using Filter paper method &Time for Hemostasis. Total amount of blood loss using Gravimetric method, Wound healing scale using Landrys healing index, Post- operative complications, Satisfaction – 5 point Likert scale, Post-operative Pain using VAS & Need for any other hemostatic interventional methods like bonewax, cautery etc..
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients aged 40-60 Years.
- •2.Patients on dual antiplatelet therapy 3.Patients requiring single molar tooth extraction 4.Patients willing to consent for the study.
排除标准
- •1.Patient with INR more than
- •2.Patients with Periapical pathology, requiring Trans alveolar extraction, Patients with Uncontrollable Blood Pressure greater than 140/90 mm of Hg and Diabetes Mellitus, Liver disease, Alcoholics, Smokers and Patients on Anticoagulants or on Other Allied Medications, Hemostasis Achieved more than 20 Minutes.
结局指标
主要结局
Hemostasis confirmed using Filter paper method & to measure the time for Hemostasis in each of the interventional groups.
时间窗: Immediately after the extraction, for 8 minutes.
次要结局
- Total amount of blood loss using Gravimetric method(Wound healing scale using Landrys healing index)
研究者
Dr Talari Divya Sri
Oral & Maxillofacial Surgery Department
