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临床试验/NCT05670899
NCT05670899尚未招募不适用

Retention of CAD Metallic and Poly Ether Ether Ketone (PEEK) Frameworks in Mandibular Kennedy Class I Cases: a Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
retention

研究概览

简要总结

comparing retention of CAD CAM metallic and Poly Ether Ether Ketone (PEEK) partial dentures in Kennedy class I casses

详细描述

partially edentulous patients with Kennedy class I classification will be recruited for the trial and then randomly distributed on two groups; experimental group will receive CAD CAM PEEK partial denture and control group will receive CAD CAM metallic partial denture. then primary impressions will be made and then mouth preparation followed by secondary impression then scanning of the master cast using extra-oral scanner then designing the partial denture using blender for dental then the frame work will be printed.

then frame work will be processed into either PEEK or Metal according to randomization.

retention will be measured at zero and 3 months.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.
  • •2- Opposing dentition is fully intact or restored. 3- Sufficient inter-arch space. 4- Angle's class I maxilla-mandibular relationship.

排除标准

  • •Periodontal affection of the abutment teeth.
  • •Skeletal mal-relation.
  • •Unmotivated patients to maintain adequate oral hygiene to follow up.
  • •Patients with neuromuscular and Psychiatric disorders.
  • •Systematic disease affecting bone and periodontal health.
  • •Insufficient inter-arch space.
  • •Patients with physical reasons that could affect follow up.

研究组 & 干预措施

CAD PEEK frame-work

Experimental

Construction of PEEK framework will be done conventionally by lost wax technique using a vacuum press device. The wax pattern will be invested in a mold using special investment. Then it will be heated and melted to produce a mold into which PEEK will be vacuum pressed. The framework will be fitted on the master cast

干预措施: CAD PEEK frame-work (Procedure)

CAD metallic frame-work

Active Comparator

A metallic framework will be obtained using the conventional lost wax technique and casting. After de-investing, finishing and polishing, the framework will be fitted on the master cast. Intraoral try in of the framework will be done followed by bite registration record. The next step will be teeth setting and try in. Heat cured acrylic resin denture base will be processed, finished and polished conventionally. The finished removable partial denture will then be checked intraorally for any needed modifications and finally delivered.

干预措施: CAD PEEK frame-work (Procedure)

结局指标

主要结局

retention

时间窗: 3 months

Measurements are performed for each RPD at the time of denture insertion, after one month and three months later. Measurements were carried out using digital force gauge which is an advanced type of force meter device, used to measure tension or compression up to 20 Kg

次要结局

未报告次要终点

研究者

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

Amr Magdy Ibrahim

assistant lecturer

Cairo University

研究点 (1)

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