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临床试验/NCT07025525
NCT07025525尚未招募不适用

Clinical and Radiographic Evaluation of Ultrasonic Activated Irrigation Versus Non Activated Irrigation in Pulpectomy of Necrotic Primary Molars : A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Post operative pain

研究概览

简要总结

This is a Clinical and Radiographic Evaluation of Canal Irrigation Using Ultrasonically Activated vs. Non-Activated Irrigants in Pulpectomy of Necrotic Primary Molars: A Randomized Clinical Trial" This study aims to compare the effectiveness of using ultrasonically activated irrigant versus non-activated irrigant in terms of clinical and radiographic success rates in the pulpectomy of necrotic primary molars, through a randomized clinical trial.

详细描述

Primary teeth are considered of great importance to children allowing their normal, healthy development and growth while preserving function, eating, speech and normal development of occlusion while preserving the space for permanent dentition and guide their eruption.

Pulpectomy of primary molar teeth is considered as reasonable treatment approach to ensure either normal shedding or long term survival of 1ry teeth as fully functional component in dental arch.

Treatment of necrotic primary teeth is complex due to anatomical and physiological characteristics and high no. of bacterial species present in endodontic infection.

Treatment success depend on the elimination of root canal infection which can be done mechanically and chemically to ensure the complete removal of bacterial canal infection.

Irrigation is a key part of successful root canal treatment. It has several important functions, the most important one that it has a washing effect and an antimicrobial/antibiofilm effect. Irrigation is also the only way to impact those areas of the root canal wall not touched by mechanical instrumentation.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical Criteria:
  • Children aged between 4 to 7 years' old
  • Children with deep caries involving pulp in primary molars
  • History of abscess, swelling or pus
  • Pain on percussion
  • Mobility grade 1
  • Radiographic criteria:
  • Root resorption due to abscess less that ⅔ of root
  • Periapical RL or furcation RL
  • Widening in PDL space or loss of lamina dura continuity

排除标准

  • Clinical criteria: -
  • Refusal of participation.
  • Patient unable to attend to follow up
  • Non-restorable tooth.
  • Medically compromised patient.
  • Uncooperative patient

结局指标

主要结局

Post operative pain

时间窗: 6 months

Post operative pain assessments will be clinically , binary yes or no oral from patients word

Soft tissue pathology

时间窗: 6 months

This outcome will be measured clinically , binary yes or no by visual inspection

Pain on percussion

时间窗: 6 months

Will measured clinically , binary yes or no using back of mirror for percussion assessment

Pathological mobility

时间窗: 6 months

Will be assessed clinically , binary by yes or no using back of mirror and finger of one hand to check mobility

次要结局

  • Furcation or periapical pathology(6 months)
  • External or internal root resorption(6 months)

研究者

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

Naira Essam Farouk

Internal resident

Cairo University

研究点 (1)

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