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临床试验/NCT03544528
NCT03544528Unknown不适用

Necrotic Immature Teeth Treated by Regeneration or Apexification: A 3-dimensional Analysis

Umeå University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年8月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
34
试验地点
1
主要终点
Volumetric Comparison of hard tissue formation

研究概览

简要总结

Dental trauma injuries during childhood may have an adverse impact on oral health throughout life. If trauma injuries causes pulpal necrosis, then the root stop forming. These teeth have consequently a questionable long-term survival.

Dental management of necrotic teeth with aberrant root formation represents a challenging clinical situation. The classical approach for treating these teeth includes apexification. Both apexification with Calcium hydroxide and MTA do not achieve the goals of continued root development or restoration of pulp tissue functionality.

In the last decades, a biological based approach referred as "revascularization", or "regeneration" has emerged as a biological treatment for necrotic pulps with aberrant root development. This treatment aims to regenerate pulp-like tissue within the root canal space after inducing an influx of stem cells from the apical papilla that results in reestablishment of pulp protective functions. There is evidence supporting the regeneration potential of dental tissues after regenerative endodontic treatment. However, root formation in traumatized immature teeth seems variable.

The overall goal of this study is to gain knowledge about the treatment of immature necrotic teeth in young individuals due to dental trauma. The primary goal is to compare volumetric hard tissue formation between the MTA apexification and the regeneration treatment.

详细描述

A randomized controlled trial, employing 34 young individuals aged 6-18 years, with immature necrotic teeth will be included. The test group will be treated by the regeneration procedure and the control group by the application of an MTA-plug. Clinical and low-dose cone-beam computed tomography scans (preoperatively and at 18-months follow-up) will be retrieved. Clinical data with information about tooth survival, absents of symptoms, resolution of infection and root development will be taken at every session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Immature teeth and confirmed pulp necrosis caused by dental trauma.
  • Teeth with apical opening larger that 1mm observed in the initial CBCT.

排除标准

  • Extensive loss of coronal tissue that require restoration with a post that will occupy the space required for blood clot formation.
  • Patients who had received antibiotic treatment during the previous 3 months.

结局指标

主要结局

Volumetric Comparison of hard tissue formation

时间窗: 18 months

3- dimensional analysis of regenerative treatment outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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