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临床试验/NCT02931903
NCT02931903已完成不适用

The Effect of Lithium Disilicate Glass-ceramic (IPS Emax) Versus Hybrid Ceramic (Vita Enamic) Superstructure Materials on Implant Stability in Implant Supported Restorations

Cairo University0 个研究点目标入组 20 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
Implant survival rate

研究概览

简要总结

The aim of this study is to assess the effect of the newly introduced (hybrid dental ceramic) superstructure materials, Vita Enamic versus IPS Emax on implant stability, patient satisfaction and crestal bone loss.

详细描述

This study will be conducted on patients requiring single implant replacement in the maxillary premolar area, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University.

After a period of healing of 6 months, an implant abutment of accurate diameter and angulation will be placed to fit precisely into the internal hex of the fixture after removal of the cover screw. The platform matched abutment will be then secured into its final position using the abutment screw. Alginate impression will be taken and poured into dental stone. Using the impression transfers, impressions with polyvinylsiloxane are taken. After taking the impressions, the Impression transfers are removed and fixed to the implant replica.

Surgeons' assistants will be asked to open the sealed envelope containing the information regarding the crown placement. The impressions will be sent to dental laboratory with the result of the sealed envelope, for preparation of the future crowns, either vita enamic crowns or Ips e max crowns.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
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

  • Patients > 18 yrs. Patients with missing teeth in the maxillary premolar region. Absence of any pathological condition in the recipient site.
  • Stabilization phase will be performed including:
  • Debridement.
  • Elimination of all carious cavities and root canal treatment if needed.
  • Elimination of over-hanging restoration. Systemic condition of the subjects was evaluated according to dental modification of the Cornell medical index (Kerr and Millard 1966).
  • Patients who are cooperative, motivated, and hygiene conscious. Patients should have adequate ridge width (>5mm).

排除标准

  • Patients unable to undergo minor surgical procedure. Patients with history of drug abuse or metabolic drugs. Patients with history of psychiatric disorder. Patients with insufficient bone. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
  • Patients with any systemic condition that may contraindicate implant therapy. Patients that may have any habits that may jeopardize the osseo-integration process, such as heavy smoking and alcoholism.
  • Patients with para-functional habits that produce overload on the implant such as bruxism and clenching.

结局指标

主要结局

Implant survival rate

时间窗: 12 months

Implant stability and success could be affected by crestal bone loss, if the implant is stable therefore high survival rate

次要结局

  • Crestal bone loss(12 months)
  • Patient satisfaction(12 months)
  • Peri-implant tissue response(12 months)

研究者

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

Sally Edward Fekry

Assistant Lecturer

Cairo University

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