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临床试验/NCT02929173
NCT02929173Unknown2 期

Patient Satisfaction and Clinical Assessment of Biocompatible High Performance Polymers Crown Veneered With Visio.Lign Versus E-max Crown Veneered With E-max Veneering System in Anterior Aesthetic Zone.(Randomized Controlled Clinical Trial)

Cairo University0 个研究点目标入组 24 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
2 期
入组人数
24
主要终点
Change in esthetic patient satisfaction

研究概览

简要总结

The aim of this study is to compare the patient satisfaction and clinical assessment (shade matching, surface texture and marginal discoloration) of Bio- High Performance Polymers (HPP) restoration versus E-max restoration compared to contralateral tooth in anterior zone.

Regardless E-max popularity in the dental field.

详细描述

Roles and responsibilities

  1. Nora Helmy Hasaneen (N.H.): Operator, data enterer and corresponding author; Assistant lecturer fixed Prosthodontics Department, Faculty of Dentistry, Modern Technology Institution (MTI) University, Egypt.
  2. Dr. Ahmed Naguib Hussin( A.H.): Main supervisor, data monitoring and auditing; Professor of fixed Prosthodontics, Faculty of Oral and Dental Medicine- Cairo University, Egypt.
  3. Dr.Gihan Al-Naggar (A. G.):Co-Supervisor, data monitoring and auditing; Professor of fixed Prosthodontics, Faculty of Oral and Dental Medicine -Cairo University, Egypt.

3.Esraa Mohamed Odeuh(E.O.):Outcome assessors and data collection; Assistant lecturer, Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, MTI University, Egypt.

4.Ahmed Gamal(A.G): Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents; Resident Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, MTI University, Egypt.

5.Eman Desouky (E.D.):Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

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
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
  • Patients have no active periodontal or pulpal diseases, have teeth with good restorations.
  • Patient with anterior tooth with problems indicated for full coverage restoration (e.g. mild to moderate discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth) Patients are willing to return for follow-up examination and evaluation.
  • Patient with sound contralateral tooth to the selected tooth required for full coverage.
  • Patient with root canal treated tooth requiring full coverage restoration

排除标准

  • Patient in the growth stage with partially erupted teeth.
  • Patient with poor oral hygiene and motivation.
  • Pregnant women's.
  • Patient with psychiatric problems or unrealistic expectations.
  • Patients have no opposing occluding dentition in the area intended for restoration.
  • Patients with parafunctional habits.
  • Color blindness patients are excluded.
  • Patient without contralateral tooth to that tooth to will be restored.
  • Patient without adjacent teeth to that tooth will be restored.

结局指标

主要结局

Change in esthetic patient satisfaction

时间窗: At crown delivery time and after delivery 3, 6, 9, 12 month

using Rating scores from 0-2 (0= Poor, 1=Accepted, 2=Excellent)

次要结局

  • Shade match to contralateral tooth(At crown delivery time and after delivery 3, 6, 9, 12 month)
  • Surface texture(At crown delivery time and after delivery 3, 6, 9, 12 month)
  • Marginal discolouration(At crown delivery time and after delivery 3, 6, 9, 12 month)

研究者

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

Nora helmy hassaneen

assistant lecturer of fixed prosthodontic department,MTI university

Cairo University

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