跳至主要内容
临床试验/CTRI/2025/09/095248
CTRI/2025/09/095248招募中3 期

Comparison of post-extraction hemostasis in 4-12-year-old children using pressure pack with absorbable gelatin sponge or feracrylum- A randomized controlled trial

Dr Nikita Khachane1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年11月21日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
180
试验地点
1
主要终点
Post-extraction haemostasis

研究概览

简要总结

The trial is underway, to be completed by May 31, 2026.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 4 to 12 year old otherwise healthy children.
  • Children requiring routine dental extractions such as due to caries or trauma or for orthodontic purpose of primary teeth.

排除标准

  • Children with systemic illness having any impact on blood profile
  • Children under medication that can alter coagulation profile
  • Children requiring surgical extraction, extraction with the use of elevators
  • Children requiring extraction of permanent teeth
  • Children with Grade 3 mobile teeth
  • Rootless teeth
  • Children whose parents do not provide consent.

结局指标

主要结局

Post-extraction haemostasis

时间窗: Post-extraction haemostasis will be assessed at the following time points. At | T0 (Immediately post-extraction) At T1 (10 minutes post-extraction) At T2 (30 | minutes post-extraction) At T3 (45 minutes post-extraction) At T4 (24 hours post-extraction)

次要结局

  • Harms (if any).(In a 24 hour post-extraction follow-up, harms assessed include bleeding, pain,)

研究者

发起方
Dr Nikita Khachane
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Dr Nikita Khachane

Bharati Vidyapeeth (Deemed to be University) Dental College & Hospital Navi Mumbai

研究点 (1)

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