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临床试验/NCT04073901
NCT04073901已完成不适用

Clinical Evaluation of Endocrowns Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars : A Pilot Prospective Clinical Study

Nahda University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年2月2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
marginal adaptation

研究概览

简要总结

Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy beautiful smile rather than achieving only a beautiful smile. The objective of this study was to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the restoration of pulpotomized primary molars and parental satisfaction toward these crowns. Study design: Randomized clinical trial/split mouth design compared the clinical outcomes of two coronal restorations, on patients with bilateral carious second primary molars restoring one side with Endocrown (IPS e.max Press) and the other side with zirconia crown. Children attended Nahda University; Faculty of Dentistry clinics who need restorations screened for inclusion criteria till 20 patients are recruited (20 teeth for zirconia crown restorations and 20 for Endocrowns restorations). All children fulfilled the inclusion criteria were evaluated for factors including restoration integrity, marginal adaptation, marginal discoloration, oral health and overall clinical success at 3,6,12 months while parental satisfaction at 12 months follow up..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

only satiation was blinded

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • . Free of systemic diseases.
  • Age between 4 and 7 years.
  • Takes no medication on regular basis.
  • Has bilateral lower second primary molar with deep carious lesion, indicated for pulp therapy and crown restoration. (split mouth)
  • Patient and parent compliance.

排除标准

  • Non-restorable tooth.
  • Tooth near its exfoliation.
  • Tooth with extensive root resorption or periapical pathosis.

结局指标

主要结局

marginal adaptation

时间窗: one year

Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

marginal discoloration

时间窗: one year

Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

Restoration integrity

时间窗: one year

Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

次要结局

  • parent satisfaction(immediate after intervention)

研究者

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

Yassmine mohamed farouk el makawi

Assistant lecturer

Minia University

研究点 (2)

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