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临床试验/NCT05597553
NCT05597553尚未招募不适用

Clinical and Radiographic Evaluation of Premixed Verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 24 人开始时间: 2023年1月1日最近更新:
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
Post operative pain

研究概览

简要总结

Evaluate Clinical and Radiographic Evaluation of Premixed verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars

详细描述

Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability, and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth.

Although it has good properties, MTA has many limitations, including long setting time, handling property and tooth discoloration making the use of this material challenging for many clinicians.

Researchers and manufacturers have made progress in overcoming these problems in recent years, new and improved products are becoming available such as the premixed bioceramic putty.

The premixed bioceramics putty are ready to use materials, fast setting, with superior handling properties and hydrophilic in nature that necessitate moisture from the adjacent tissues to set. They have advantage of insensitive to moisture and blood contamination with less technique sensitive. Upon setting, they become hard and expand slightly providing with superior long-term seal.

Premixed Bio-ceramics (BC) are highly alkaline materials (pH = 12.7), they release calcium and have antibacterial activity. Their biocompatibility is higher than that of MTA, this is attributed to the absence of heavy metals from the premixed BC components.

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, Investigator)

入排标准

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

入选标准

  • Medically fit and cooperative children.
  • Pediatric patients aged 6-8 years.
  • Deep caries with reversible pulpits in immature first permanent mandibular molars indicated for indirect pulp capping.
  • Absence of clinical signs and symptoms of pulpal exposure.
  • Absence of radiographic signs and symptoms of pulp degeneration.
  • Positive parental informed consent.

排除标准

  • Clinical symptoms of irreversible pulpitis requiring endodontic treatment.
  • Clinical symptoms of pulp exposure.
  • The presence of fistulas or swelling.

结局指标

主要结局

Post operative pain

时间窗: 12months

Clinical examination by(Visual Analogue Scale) System (0 - Mild - Moderate - Severe)

次要结局

  • Absence of furcal radiolucency or root resorption(12months)
  • Pulp vitality(12months)

研究者

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

Aisha Magdy Khairy Abozaid

Principal Investigator

Cairo University

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