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临床试验/NCT04982510
NCT04982510已完成不适用

Retention of 3D Printed Bases Using Prefabricated Thermoplastic Trays and Conventional Custom Impression Trays: Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Maxillary complete denture base retention

研究概览

简要总结

the aim of this crossover randomized controlled clinical trial is comparing retention of 3D printed maxillary complete dentures produced from thermoplastic impression trays and conventional acrylic impression trays.

The research hypothesis is that there is no difference in patient satisfaction and retention of dentures constructed from definitive impression using the conventional tray and the prefabricated thermoplastic tray

研究设计

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

入排标准

年龄范围
— 至 69 Years(Child, Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Male edentulous patients.
  • •Cooperative and highly motivated patients.
  • •Patients with well or moderately developed ridges and healthy attached mucosa of appropriate thickness free from inflammation

排除标准

  • •Patients with recent extraction less than 3 months ago
  • •Patients with Parkinson's disease
  • •Patients with xerostomia.
  • •Patients with allergy to resins.
  • •Pathological changes of residual ridges.
  • •Patient with sever undercuts, or irregular bony exostosis.
  • •Patients with flabby and flat ridges.
  • •Patients with medical or psychological conditions that hinder co-operation.
  • •Patients with class II or III jaw relation.

研究组 & 干预措施

Thermoplastic tray definitive impression

Experimental

干预措施: complete denture (Device)

Conventional tray definitive impression

Active Comparator

干预措施: complete denture (Device)

结局指标

主要结局

Maxillary complete denture base retention

时间窗: 2 weeks after denture insertion

A loop will be attached to each denture base at the position of geographic center using self cure acrylic resin and the retention will be measured by applying the forces perpendicular to the denture using Digital Force Meter Each base will be tested 3 times and the average will be calculated.

次要结局

  • Patient satisfaction(2 weeks)

研究者

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

Sonal Abdelbaseer

Principal investigator

Cairo University

研究点 (1)

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