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临床试验/NCT05431465
NCT05431465招募中不适用

Evaluation of Wear Behavior of Onlay Restorations Constructed From Two Types of Glass Ceramics

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Wear evaluation

研究概览

简要总结

The 1ry objective will be to evaluate the amount of wear of onlays restorations made from VITA AMBRIA & IPS e.max Press and their opposing natural teeth.

  1. The 2ry objective of the clinical trial will be to evaluate the fractures, retention, contact points, food impaction and radiographic examination of the VITA AMBRIA onlays compared with IPS e.max press onlays as defined by FDI criteria.

详细描述

A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations are evaluated by a blind and calibrated two examiner using the FDI World Dental Federation criteria. A total of 24 patients will be randomly assigned to each group for a total of 48 patients. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.

Both groups will receive Onlay preparation . Digital impression by intra oral scanner will be taken, wax pattern for the onlay restoration will be designed and milled using CAD/CAM software. After that, the wax pattern will be invested and final onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions. Primary outcome: The amount of wear will be evaluated according to FDI standard.

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

  • The patient is healthy.
  • 18-50 years old.
  • Normal occlusion.
  • Good oral hygiene.
  • Tooth with complete root apex.
  • Tooth with moderate coronal decay.

排除标准

  • Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.

结局指标

主要结局

Wear evaluation

时间窗: 1 year follow up

The amount of wear will be defined as follows: 1. Intra oral scanner will be used to scan the surface of the restorations and opposing natural enamel after achieving a complete dry surface by isolation. 2. The recordings that measured at base line and 12 month periods will be superimposed on each other by specific software. 3. Mean values and standard deviations of the amount of wear for all restorations' and opposing enamel's will be statistically analyzed.

次要结局

  • contact points and food impaction(1 year follow up)
  • Radiographic examination(1 year follow up)

研究者

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

Abd Elaziz Helmy Abd Elaziz Mahmoud Elhamrawy

Assistant lecturer, Department of Crown&Bridge,Al-Azhar Unverisity

Al-Azhar University

研究点 (1)

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