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临床试验/NCT06922578
NCT06922578尚未招募不适用

Clinical and Radiographic Success of Pulpotomy Using Neoputty Mineral Trioxide Aggregate Versus Pulpectomy Using Endoflas In Primary Molars With Irreversible Pulpitis: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 66 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
主要终点
postoperative pain

研究概览

简要总结

The goal of this randomized clinical trial is to evaluate the clinical and radiographic success of pulpotomy using Neoputty MTA vital primary molars diagnosed with symptomatic irreversible pulpitis.

The main question it aims to answer is:

Will Neoputty MTA pulpotomy have higher clinical and radiographic success in comparison to Endoflas pulpectomy in primary molars with irreversible pulpitis?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children with spontaneous pain lasting a few seconds to several hours.
  • •Pain is intensified by thermal stimulus and persists after its removal.
  • •Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
  • •Radicular pulp health is verified by achieving hemostasis within six minutes of compression using a cotton pellet with 2% sodium hypochlorite.
  • •Absence of peri-apical or inter-radicular radiolucency, widening of periodontal ligament space, internal or external root resorption.

排除标准

  • •Unrestorable primary molars.
  • •Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
  • •Medically compromised patients who have systemic disease.
  • •Uncooperative children who refuse treatment.

研究组 & 干预措施

Neoputty MTA pulpotomy

Experimental

干预措施: NeoPUTTY MTA pulpotomy (Procedure)

Endoflas pulpectomy

Experimental

干预措施: Endoflas pulpectomy (Procedure)

结局指标

主要结局

postoperative pain

时间窗: within 24 hours, after 1 week, 3, 6, 9, and 12 months

postoperative pain will be assessed using the visual analogue scale (VAS) within 24 hours, after 1 week, 3, 6, 9, and 12 months. The patients are asked to point to the face that best represents how they are feeling at the follow-up visits.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manar Motawie Abdulfattah

DR.

Cairo University

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