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临床试验/NCT06293521
NCT06293521招募中2 期

Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
40
试验地点
1
主要终点
Radiographic assessment

研究概览

简要总结

This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits

详细描述

Background: Pulpectomy is the reference treatment for vital primary molars with irreversible pulpitis.Over the past decades, dental caries has unfailingly been the most common chronic infectious disease of childhood and adults. If remained untreated, it can potentially compromise dental pulp tissue. When the dental pulp of primary teeth is irreversibly inflamed, the first treatment choice is pulpectomy, owing to the well-recognized importance of primary tooth retention for child oral/general health. Although a pulpless tooth can remain functional in the oral cavity, modern pediatric endodontics encourages regenerative approaches in primary teeth.The introduction of calcium silicate-based (CS-B) biomaterials such as mineral trioxide aggregate (MTA), along with further understanding of pulp biology and inflammatory processes, has revolutionized treatment modalities for management of irreversible pulpitis in mature permanent teeth. A growing body of evidence has revealed successful implementation of minimally invasive endodontics, that is, vital pulp therapies (VPTs) for management of permanent teeth with irreversible pulpitis even when associated with apical periodontitis. Due to the traditional notion of poorer healing capacity of primary dental pulp, such a paradigm shift has not been seen in pediatric dentistry.Recent research revealed similar vascular/immune responses of primary and permanent dental pulps to caries; therefore, indicating that their healing potential might be this in mind, a reevaluation of traditional approaches for treatment of inflamed primary pulp seems justified.

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 (Participant)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 4 to 6 years , in good general health
  • The parents provided written informed consent.
  • Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue.
  • Restorable teeth.

排除标准

  • Physical or mental disability.
  • Unable to attend follow-up visits.
  • Previously accessed teeth.
  • Swelling, tenderness to percussion or palpation, or pathological mobility.
  • Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.

结局指标

主要结局

Radiographic assessment

时间窗: Month 6 , Month 12

Absence of periapical radiolucency or absence of internal/ external root resorption

次要结局

  • Clinical effectiveness(Month 3,Month 6,Month 9,Month 12)
  • Child cooperation(Day 0)
  • Time elapsed till final restoration performed(Day 0)
  • Clinical effectiveness(Month 3,Month 6,Month 9,Month 12)
  • Child cooperation(Day 0)
  • Time elapsed till final restoration performed(Day 0)

研究者

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

Nada Mohamed Hassan Mostafa

Principal Investigator

Cairo University

研究点 (1)

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