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临床试验/NCT06864091
NCT06864091招募中不适用

Esthetic Evaluation of Facial Prostheses Fabricated Using Direct and Indirect Additive Manufacturing Techniques: A Pilot Randomized Crossover Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
5
试验地点
1
主要终点
Esthetic Outcomes

研究概览

简要总结

All participants will undergo 3-dimentional facial scan and the defect site will be scanned using intraoral scanner. the data will be extracted in Standard tessellation Language (STL) and used in virtual prosthesis reconstruction.

  • (Group 1) involves direct printing of the final prosthesis using biocompatible rubber-like printable soft resin.
  • Group 2, involves direct manufacturing of the negative mold, it will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern.
  • Group 3, involves fabrication of the negative mold indirectly by printing the prosthesis prototype from resin and then duplicating it into wax and a conventional stone mold will be fabricated.
  • The negative molds of both groups 2&3 will be used in packing medical grade silicone (to cast the final prosthesis.
  • All final prostheses will be colored and characterized to match the surrounding anatomy.
  • Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5.
  • Prosthesis accuracy will be assessed using Medit software, comparing the scan of the final prosthesis to the STL of the prosthesis design and the root mean square (RMS) will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cartilaginous facial defects, i.e: auricular and nasal defects.
  • Patients between 20-60 years old.
  • Post traumatic patients with facial defects.
  • Patients with congenital facial defects.
  • Patients with failed facial surgical construction.
  • Compliant and cooperative patients.

排除标准

  • 1 - Patients having risk of tumor recurrence in the defect area. 2- Patients undergoing radiotherapy or chemotherapy treatment. 3- Patients with any debilitating disease. 4- Patients with any type of psychosomatic disorder. 5- Patients with allergy to any of the materials used.

结局指标

主要结局

Esthetic Outcomes

时间窗: 3 months

Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5.

次要结局

  • Prosthesis Accuracy(3 months)

研究者

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

Fatima Elmougi

Doctor

Cairo University

研究点 (1)

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