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临床试验/NCT04738513
NCT04738513Unknown不适用

One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques (Randomized Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Marginal integrity

研究概览

简要总结

The aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5Y-TZP/3Y-TZP).

详细描述

Introduction

A good relationship between dental restorations and the periodontium is one of the most important aspects to ensure clinical success both in terms of esthetics and function. Dental preparation for fixed prostheses can take various forms classified as horizontal preparation with a defined margin (chamfer), or vertical, or without a margin/finish line. According to some clinical reports, vertical preparation technique provides an increases in the gingival thickness and a greater stability of the gingival margin. Moreover, vertical preparation is characterized by being more conservative with tooth structure. Also, taking impressions is easier since it is a finish area and not a defined line.

Null hypothesis:

  1. There will be no difference between vertical and conventional preparations in the clinical behavior of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
  2. There will be no difference between vertical and conventional preparations in the patient satisfaction of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •From 21-50 years old, be able to read and sign the informed consent document.
  • •Have no active periodontal or pulpal diseases, have teeth with good restorations.
  • •Psychologically and physically able to withstand conventional dental procedures.
  • •Patients with teeth problems indicated for all ceramic crowns in esthetic zone;
  • •Badly decayed teeth
  • •Teeth restored with large filling restorations
  • •Endodontically treated teeth
  • •Malformed teeth
  • •Malposed teeth (Tilted, over-erupted, rotated, etc.)
  • •Able to return for follow-up examinations and evaluation.
  • •Thick gingival biotype.

排除标准

  • •Patient less than 21or more than 50 years.
  • •Patient with active resistant periodontal diseases.
  • •Patients with poor oral hygiene and uncooperative patients.
  • •Pregnant women.
  • •Patients in the growth stage with partially erupted teeth.
  • •Psychiatric problems or unrealistic expectations.
  • •Patient with periodontal problems.
  • •Patients with malocclusion or parafunctional habits.

研究组 & 干预措施

Conventional preparation technique

Active Comparator

Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.

干预措施: Conventional Preparation technique (Procedure)

Vertical preprartion

Experimental

Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using Vertical preparation technique.

干预措施: Vertical preparation technique (Procedure)

结局指标

主要结局

Marginal integrity

时间窗: 1 year

Measured by using Modified United States Public Health Service criteria (USPHS criteria) * Alpha (A) the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration (visual inspection explorer) * Bravo (B) the explorer catches and the is visible evidence of the crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile ( visual inspection and explorer) * Charlie (C) the explorer penetrates crevice defect extended to the dento-enamel junction (explorer)

次要结局

  • Gingival inflammation(1 year)
  • Secondary caries(1 year)
  • Gingival discoloration(1 year)
  • Restoration color stability(1 year)
  • patient satisfaction(1 year)

研究者

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

Mennatalla Ahmed Emad ElGendy

Principal investigator

Cairo University

研究点 (1)

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