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临床试验/NCT05708339
NCT05708339已完成不适用

Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects: a Randomized Controlled Trial.

Fatima Elmougi1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年12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
已完成
发起方
入组人数
15
试验地点
1
主要终点
Prosthesis adaptation using Silicon replica measuring technique.

研究概览

简要总结

: patients were recruited for auricular prosthetic reconstruction. Preoperative data was collected including personal and medical history, plain photographs and CT scans. Pre-operative prosthetic and implant planning were carried out. Three endosseous implants were placed in a two-stage surgical technique. Patients were assigned into two groups with allocation ratio 1:1. In control group, Implant level impression was recorded, and a stone model of the defect was cast. waxing up of the ear was done on the stone cast followed by flasking, wax elimination, packing of heat cured acrylic resin and curing. In intervention group, CT scanning was done to the full head and optical scanning was done to the defect site with scan bodies screwed to the implants. Using Exocad software a model of the defect site with implant analogues and ear model with abutment extensions were planned and printed using SLA printing technology. A placement jig was done for ear models of both groups and adaptation was measured on the patient using silicon replica technique. The silicone replica was sectioned and the gap, represented in light consistency polyvinyl siloxane impression material was measured using digital microscope.

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
Single (Participant)

入排标准

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

入选标准

  • •Patients with missing or severely deformed ears.
  • •Patients with failed autogenous reconstruction.
  • •Compliant and cooperative patients.
  • •Patients committed to maintain the prosthesis.
  • •Patients willing to attend the follow up appointments.

排除标准

  • •Patients undergoing radiotherapy or chemotherapy treatment.
  • •Patients taking corticosteroids or bisphosphonates.
  • •Patients with contraindications for CT scanning.
  • •Patients with any debilitating medical condition.
  • •Patients with any type of psychosomatic disorder.
  • •Patients allergic to any of the materials used.

研究组 & 干预措施

conventionally fabricated ear prosthesis

Active Comparator

干预措施: conventionally fabricated ear prosthesis (Other)

virtually fabricated ear prosthesis

Experimental

干预措施: virtually fabricated ear prosthesis (Other)

结局指标

主要结局

Prosthesis adaptation using Silicon replica measuring technique.

时间窗: Day 1

measuring gap between prosthesis and defect

次要结局

未报告次要终点

研究者

发起方
Fatima Elmougi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatima Elmougi

Doctor

Cairo University

研究点 (1)

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