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临床试验/CTRI/2025/11/096963
CTRI/2025/11/096963尚未招募Unknown

Comparative Evaluation of Hemocoagulase , Chitosan Dental Dressing, Cologenesis collagen plug® After Dental Extractions in Patients Undergoing Antiplatelet Therapy- A prospective clinical study

Jayneel H Raichura1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
45
试验地点
1

研究概览

简要总结

This prospective three arm clinical study evaluates the effectiveness of three local hemostatic agents applied after simple tooth extraction in adults receiving antiplatelet therapy. Participants are allocated to one of three interventions hemocoagulase solution or gel, chitosan dental dressing, or collagen plug. The primary purpose is to determine which agent achieves faster control of bleeding and supports better early wound outcomes without increasing complications. The primary outcome is time to hemostasis in minutes measured immediately after extraction. Secondary outcomes include wound healing scores on days 3, 7, and 14, postoperative pain on a visual analogue scale, secondary bleeding events, dry socket, infection, rescue measures, analgesic use, patient satisfaction, and adverse events up to 14 days. Hypothesis: at least one of the three agents will reduce time to hemostasis and improve short term postoperative outcomes compared with the others in patients on antiplatelet therapy.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 70 years Patients indicated for at least one simple tooth extraction Patients on stable antiplatelet monotherapy Patients with INR 1.5 to 3.5 and if are co-prescribed with anticoagulants.

排除标准

  • Allergy to any study agents Immunocompromised or diabetic patients Current infection at extraction site On anticoagulant or dual antiplatelet therapy Pregnant/lactating women.

研究者

发起方
Jayneel H Raichura
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jayneel H Raichura

DeDr D Y Patil Dental College and Hospital

研究点 (1)

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