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临床试验/NCT06231823
NCT06231823进行中(未招募)不适用

The Extraction of Compromised First Permanent Molars in a Group of Egyptian Children

Ain Shams University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
37
试验地点
2
主要终点
clinical spontaneous space closure

研究概览

简要总结

Compromised first permanent molars (FPM), whether diagnosed with severe molar incisor hypomineralization (MIH), irreversible pulpities, or necrosis, require frequent re-treatment consequently entering the restorative cycle, which leads to their inevitable extraction and implant placement. Extraction of compromised first permanent molars in 8-10-year-old children allows the mesial migration of the second permanent molars during their eruption, thereby favoring spontaneous space closure as a permanent solution.

详细描述

Extraction of compromised first permanent molars in children decreases the burden of repeated restorative procedures for theses molars, which will eventually need frequent repair. This will end in their inevitable extraction with its consequences. The extraction of the FPM will be delivered by Nour Wahba, Dina Darwish, and Basma Nagi, lecturers in Pediatric Dentistry and Dental Public Health Department, faculty of Dentistry, Ain Shams University.All patients will be recalled for follow-up yearly for three-years. The first follow-up will be done after 6months to perform the Quality of life questionnaires. The position of the second permanent molar will be checked clinically and radiographically to evaluate the space between second premolar and the second molar.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy patients' class I according to the American Society of Anesthesiologists (ASA class I)
  • Age: 8-10 years
  • Angle class I occlusion
  • The radiographic presence of the second premolar
  • The radiographic stages of development E or F for formation the second permanent molar.
  • First permanent molar that is severely affected by MIH, signs of necrosis, signs of irreversible pulpitis or non-restorability.

排除标准

  • Refusal of the parents to sign the informed consent.
  • Signs of reversible pulpitis of first permanent molar.
  • Patients with severe malocclusion.

结局指标

主要结局

clinical spontaneous space closure

时间窗: 3 years

Clinically, using periodontal probe measure the amount of space between the distal surface of second premolar and mesial surface of second permanent molar.

radiographic spontaneous space closure

时间窗: 3 years

radiographically, using panoramic radiograph

次要结局

  • assessment of the Quality of life(6 months)
  • Midline shift(3 years)

研究者

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

dina darwish

lecturer

Ain Shams University

研究点 (2)

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