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临床试验/NCT04620174
NCT04620174已完成不适用

Custom-made Versus Prefabricated Zirconia Crowns for Primary Molars; a Clinical Trial With 12-month Follow-up.

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in periodontal health.

研究概览

简要总结

Background: Do construction methods of pediatric zirconia crowns affect the periodontal health and clinical performance of badly decayed primary molars? The question asked by many practitioners.

Purpose: to compare the periodontal health and clinical performance of primary molars restored with custom-made and prefabricated zirconia crowns. Hypothesis is the performance of primary molars restored with custom-made zirconia crowns will be equivalent to those restored with prefabricated zirconia crowns.

详细描述

This study is a randomized, 12-month follow up clinical trial. According to sample size calculation, ten patients will be selected in conjunction with departments of Pedodontics and Crowns & Bridges. The study will be conducted in accordance with the principles of the Research Ethics Committee, Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt.

The purpose of the investigation and the clinical procedures of this study will be explained to the parents and children. A written informed consent form will be signed from patient guardians and obtained prior to study initiation. The inclusion and exclusion criteria are established as the following;

  • Inclusion criteria
  1. Children of 5-9 years old.
  2. The children have at least 2 pulpotomized primary molars with no clinical signs & symptoms or periapical pathosis.
  3. Presence of an intact contralateral primary molar as a control.
  4. Willingness to participate and to continue with the follow up appointments.
  5. Clinical and radiographically confirmed dental caries extending to the middle third of dentin.
  6. Presence of teeth in opposite arch with normal occlusion.
  • Exclusion criteria
  1. Children with systemic health problem.
  2. Children with periodontal disease.
  3. Children with unilateral chewing habit or allergic to local anesthesia.
  4. Presence of parafunctional habit.
  • Clinical procedure;

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
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of 5-9 years old.
  • The children have at least 2 decayed primary molars.
  • Presence of an intact contralateral primary molar as a control.
  • Willingness to participate and to continue with the follow up appointments.
  • Clinical and radiographically confirmed dental caries extending to the middle third of dentin.
  • Presence of teeth in opposite arch with normal occlusion.

排除标准

  • Children with systemic health problem.
  • Children with periodontal disease.
  • Children with unilateral chewing habit or allergic to local anesthesia.
  • Presence of parafunctional habit.

结局指标

主要结局

Change in periodontal health.

时间窗: At 1, 3, 6 and 12 months following application.

The periodontal health will be assessed using the plaque index (PI) and the gingival index (GI)

次要结局

  • Change in clinical performance.(At 1, 3, 6 and 12 months following application.)

研究者

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

Roqaia Mohammad Alassar

Lecturer of Crowns and Bridges, Faculty of Dental Medicine for Girls, Al-Azhar University

Al-Azhar University

研究点 (2)

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