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临床试验/NCT06630156
NCT06630156进行中(未招募)2 期

Clinical and Radiographic Evaluation of Bioceramic Root Repair Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年8月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
28
试验地点
1
主要终点
radiographic parameters

研究概览

简要总结

The present clinical study wasdirected to evaluate bioceramic root repair material versus Bio MTA in Revascularization of Immature Young Permenant Teeth through:

  1. Clinical evaluation including: Pain, swelling, sinus or fistula, mobility and crown discoloration.
  2. Radiographic evaluation including: Root lengthening, continued thickening of the dentinal walls, apical closure and regression of the peri-apical lesion.

详细描述

In a young permanent tooth with pulp necrosis and apical pathosis, routine endodontic treatment may not be possible due to the immature apex it possesses. Newer methods based on the principles of revascularization and regeneration have been tried and found to be much better than the traditional methods of apexification since it helps in physiological root maturation, unlike traditional methods which result in only artificial barrier formation without root lengthening.

Revascularization is a new treatment method for immature necrotic permanent teeth. Indeed, it would provide, after treatment, a vital tooth that would be able to complete its root maturation. Three key requirements for a successful revascularization are: (a) Root canal disinfection; (b) matrix inside the canal for growth of tissue (scaffold); and (c) a tight seal access filling.

Bio MTA was introduced to overcome some of the drawbacks of MTA such as handling properties and long setting time. Bio MTA has a faster setting time with good handling characteristics and biological properties. Calcium silicate based restorative cements were formulated using different calcium compounds such as calcium hydroxide, calcium oxide, calcium phosphate, calcium sulfate, calcium silicate, and calcium carbonate in combination with zirconium. The mixed cement comprises water-soluble calcium and phosphate and immediately forms hydroxyapatite during and after setting.

A Total Fill biocearmic root repair material which is calcium silicate-based cement was developed with excellent handling properties as it is supplied in premixed packages (putty) that do not require preparation before use. It is mainly composed of calcium silicate, monobasic calcium phosphate, calcium hydroxide, and zirconium oxide. It has antibacterial and antifungal activities. It is claimed that the material is biocompatible with human periodontal tissues.

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)

盲法说明

The statistician and the assessor were blinded, but the operator was not because of the nature of the study

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child with an age ranged from (7-12) year from both sexes.
  • Patient and parent cooperation.
  • Non vital immature permanent teeth indicated for endodontic treatment as a result of pulp necrosis.
  • Patient is not taking antibiotic and has not taken for the past 2 weeks.
  • Restorable teeth.
  • The root to crown ratio should be at least 1:1.

排除标准

  • Patients allergic to any drug used in this RCT.
  • Patients with any systemic disease that would contraindicate pulp therapy (rheumatic fever, infective endocarditis, leukemia, corticosteroid therapy and immune suppressed children).
  • Tooth with vital pulp or complete root formation.
  • Teeth with draining sinus or periodontal weak mobile teeth.
  • Teeth with internal or external root resorption.
  • Tooth with root fracture.

研究组 & 干预措施

Bio-MTA revascularization

Active Comparator

干预措施: Revascularization of Immature Young Permenant Teeth (Biological)

Total Fill biocearmic root repair material revascularization

Active Comparator

干预措施: Revascularization of Immature Young Permenant Teeth (Biological)

结局指标

主要结局

radiographic parameters

时间窗: baseline, 3, 6, and 12 months after treatment

continued root lengthening and thickening of the dentinal walls in mm

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

Reda Mohammed Mohammed Elsayed

assistant lecturer

Al-Azhar University

研究点 (1)

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