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临床试验/NCT03813433
NCT03813433尚未招募不适用

Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 24 人开始时间: 2023年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
主要终点
discoloration

研究概览

简要总结

the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth

详细描述

The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem.

In the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture.

Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue.

MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties.

Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age of patient range from 8-14 y.
  • Patients are free from any systemic diseases that may hinder the normal healing process.
  • Non vital permanent anterior teeth with open apex.
  • Pulp space not needed for post and core for final restoration.
  • Compliant patient/parent.

排除标准

  • Patients having allergy to medicaments and antibiotics necessary to complete the procedure.
  • Tooth with vital pulp or complete root formation.
  • Teeth with internal or external root resorption.
  • Un-cooperative patients

结局指标

主要结局

discoloration

时间窗: 12months

Asking patient question (Binary:present or absent)

dicoloration

时间窗: 6 months

Asking patient question (Binary:present or absent)

次要结局

  • Root lengthening(6 and 12 months)
  • Sinus or fistula(1,3, 6, 9 and 12 months)
  • Pain on percussion(1,3, 6, 9 and 12 months)
  • post operative pain(1,3, 6, 9 and 12 months)
  • color stability(1,3, 6, 9 and 12 months)
  • Swelling(1,3, 6, 9 and 12 months)

研究者

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

Rana Tarek Bartaw

Assisstant lecturer

Cairo University

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