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临床试验/NCT03589560
NCT03589560已完成不适用

Clinical and Radiographic Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Permanent Anterior Teeth (Randomized Clinical Study)

Cairo University0 个研究点目标入组 26 人开始时间: 2015年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
26
主要终点
pain on biting

研究概览

简要总结

the object of this study is to evaluate clinically and radiographically the effect of using Biodentine and Mineral Trioxide Aggregate as coronal plug materials in revascularization of non-vital immature teeth

详细描述

Traumatic injury to the anterior teeth is commonly found among young children, represent one third in boys and one fourth in girls. Because the root development completed two years after eruption of the tooth into the oral cavity, an incomplete root development is one of the most common complication seen in traumatized teeth. Loss of pulp vitality before dentine deposition is completed, leaves a weak root more susceptible to fracture as a result of the thin dentinal walls. It will also lead to a poor crown/root ratio, with possible periodontal injury as a result of increased mobility.

Several techniques have been advocated to manage the open apex of immature teeth, including calcium hydroxide (Ca(OH)2) apexification or apical barrier technique with Mineral Trioxide Aggregate (MTA). Although these techniques were successful in obtaining apical closure and healing of the apical pathosis, they have certain disadvantages, as the root walls of the immature tooth remain thin and short as hard tissue barrier formation only occurs apically, with no further root development.

As an replacement to traditional methods, the use of a regenerative endodontic procedure has been recommended as it may strengthen the root walls through the deposition of hard tissue and promote the development of a normal apical morphology. MTA was chosen to be placed over blood clot to provide excellent seal and it was considered the recommended material for regenerative procedures.The application of MTA over a blood clot was technically difficult, and condensation resulted in displacement of the material apically. Another important note was the prolonged setting time of MTA which resulted in postponing placement of composite restoration to next appointments and post-treatment tooth discoloration.

Biodentine has the same mechanical properties as human dentine, very low cytotoxicity and overcome clinical drawbacks of white MTA. It had better consistency and allow its condensation without any apical displacement. Biodentine sets within twelve minutes, which allow placement of composite restoration in the same appointment. Biodentine is tooth-colored and doesn't cause the discoloration resulted from the presence of the material at level of the orifice.

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 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients free from any systemic diseases that may hinder the normal healing process.
  • Age from 8-15 y
  • Tooth with immature root apex (apical opening greater than 1mm)
  • Traumatically or cariously exposed single rooted teeth
  • Non vital permanent anterior tooth with apical periodontitis/abscess
  • Pulp space not requiring post and core for final restoration.

排除标准

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

研究组 & 干预措施

Biodentine

Experimental

3-4 mm of Biodentine (Septodont, St. Maur-des-Fosses, France) was applied over the clot carefully in group I by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.

干预措施: Biodentine (Drug)

Mineral Trioxide Aggregate

Active Comparator

3-4 mm of white Mineral Trioxide Aggregate (Angelus, Londrina, Brazil) was applied over the clot in group II by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.

干预措施: Mineral Trioxide Aggregate (Drug)

结局指标

主要结局

pain on biting

时间窗: 12 months

Binary outcome (Present or absent). Assessed by asking the patient

次要结局

  • mobility(3, 6, 9, 12 month)
  • swelling(3, 6, 9, 12 month)
  • Sinus or fistula(3, 6, 9, 12 month)
  • pain on percussion(3, 6, 9, 12 month)
  • crown discoloration(3, 6, 9, 12 month)
  • root lengthening(3, 6, 9, 12 month)

研究者

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

Mariam Mohsen Aly

Assistant Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt.

Cairo University

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