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临床试验/CTRI/2025/09/095006
CTRI/2025/09/095006尚未招募不适用

Outcome of pulpotomy with human amniotic membrane compared to platelet rich fibrin in mature human permanent molars with symptomatic irreversible pulpitis :a randomized controlled trial

Adhya Shyam1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the outcome of pulpotomy using human amniotic membrane and platelet rich fibrin as pulpotomy agent in mature human permanent molars with irreversible pulpitis assessed by clinical criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up.

研究概览

简要总结

Usage of biological scaffold in pulpotomy procedure can enhance the regenerative potential of pulp and thereby preserve vitality of tooth without any toxic effects of overlying restorative material. Here platelet rich fibrin and human amniotic membrane are used as pulpotomy agents  in treating symptomatic irreversible pulpitis .The outcome of this procedure is assessed using ESE Guidelines 2019.

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
13.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Permanent molars with symptomatic irreversible pulpitis having spontaneous/lingering/night pain.
  • Patients above 13 years.
  • Patients and parents of patients below the age of 18 years willing to give assent and informed consent and respectively.

排除标准

  • Teeth with clinical signs or symptoms indicating pulp degeneration including swelling, sinus tract, tooth mobility and tenderness to percussion Teeth with periapical lesion ,crestal bone loss, subgingival carious lesions, internal/external resorption, calcified canals Patients with uncontrolled systemic disease.

结局指标

主要结局

To compare the outcome of pulpotomy using human amniotic membrane and platelet rich fibrin as pulpotomy agent in mature human permanent molars with irreversible pulpitis assessed by clinical criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up.

时间窗: To compare the outcome of pulpotomy using human amniotic membrane and platelet rich fibrin as pulpotomy agent in mature human permanent molars with irreversible pulpitis assessed by clinical criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up.

次要结局

  • Clinical assessment of post operative sensitivity, visible coronal discoloration, radiographically visible dentin bridge formation,diffuse canal calcifications assessed as present or absent.(clinical)

研究者

发起方
Adhya Shyam
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Adhya shyam

Government Dental College Thiruvananthapuram

研究点 (1)

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