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临床试验/NCT06432049
NCT06432049已完成不适用

Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study

Kafrelsheikh University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月5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
30
试验地点
2
主要终点
effect of different restoration on surrounding gingiva

研究概览

简要总结

Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months

详细描述

This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
10 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient age ranging from 10-13 years old with closed apex.
  • Normal occlusion without any para-functional habits.
  • Decayed lower first molar.
  • Supra-gingival margin was required after preparation.
  • Absence of root fractures or cracks.

排除标准

  • Difficulty to apply rubber dam for proper endocrown bonding.
  • Lack of patient cooperation for post-operative recall and follow up.
  • Bad oral hygiene

结局指标

主要结局

effect of different restoration on surrounding gingiva

时间窗: 6 months

gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.

number of participants with pathological changes in radiographs

时间窗: 6 months

periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings

rate of plaque accumulation on different type of restorations

时间窗: 6 months

plaque index evaluate the plaque accumulation around different type of restorations. this index involves: * Plaque index 0: No plaque is in the area adjacent to the gingiva. * Plaque index 1: There is a plaque in the form of a thin film on the gingival margin. * Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin. * Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.

degree of parent satisfaction with different restorations

时间窗: 6 month

evaluation of the extent of parent satisfaction with different type of restorations using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.

次要结局

  • degree of parent satisfaction with different restorations(1 year)
  • number of participants with pathological changes in radiographs(1 year)
  • rate of plaque accumulation on different type of restorations(1 year)
  • effect of different restoration on surrounding gingiva(1 year)

研究者

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

Ahmed Ismail Taha

lecturer

Kafrelsheikh University

研究点 (2)

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