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临床试验/NCT06976411
NCT06976411Enrolling By Invitation4 期

Prospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials

Mohamed Salah Elwakeel1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月1日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Radiographic success in terms of healing

研究概览

简要总结

The goal of this clinical trial is to evaluate healing potentiality of MTA and bioceramics materials as a root perforation repair material.

The main questions it aims to answer are:

is there is a significant difference in healing potentiality of MTA and bioceramics materials as a root perforation repair material?

Participants will:

enrollment will be from out-patients clinic of endodontic department, faculty of dentistry, Ain Shams university with root perforations. perforation repair will be done using either bio-ceramic or MTA repair material and preoperative or immediate postoperative CBCT and postoperative CBCT will be taken to compare healing.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with root perforation in lower molars.
  • Patients had anon contributory medical history.
  • Patients of age categories between 15 to 50 years old.
  • No sex restriction.
  • Small to medium size perforation.

排除标准

  • Patients with generalized chronic periodontitis.
  • Teeth with difficult isolation.
  • Non restorable teeth.
  • Medically compromised patients.
  • Patients with history of allergies to any of the medications to be used during or after the treatment.

研究组 & 干预措施

MTA

Experimental

干预措施: MTA (Drug)

Bioceramic

Experimental

干预措施: Bioceramic putty (Drug)

结局指标

主要结局

Radiographic success in terms of healing

时间窗: 1 year

Healing outcome: the presence or absence of lesion and its size were obtained by analyzing CBCT of each case and classified into: Cases with complete resolution of lesion considered as "Healed", reduction of size considered as "Healing", and no size change or increase in lesion size considered as "Failure"

patients with clinical success

时间窗: 1 year

A successful clinical outcome was defined as follows: no indication of apical periodontitis, no clinical signs and symptoms, and no loss of function.

次要结局

未报告次要终点

研究者

发起方
Mohamed Salah Elwakeel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Salah Elwakeel

Assistant lecturer

Ain Shams University

研究点 (1)

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