跳至主要内容
临床试验/NCT07035574
NCT07035574尚未招募不适用

Assessment of the Amount of Wear and Muscular Efficiency of 3D Printed Denture Teeth Versus Conventionally Fabricated Denture Teeth: A Cross-Over In Vivo Study

Cairo University0 个研究点目标入组 13 人开始时间: 2025年7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
尚未招募
入组人数
13
主要终点
Amount of Wear

研究概览

简要总结

This study aims to evaluate the wear resistance and muscular efficiency of denture teeth fabricated using two different methods: 3D printing and conventional techniques. The research is designed as a crossover in vivo study, where completely edentulous patients will receive both types of dentures sequentially. The primary outcome is the amount of wear observed in the denture teeth over time, while the secondary outcome is the muscular efficiency measured using electromyography (EMG). The study seeks to determine whether 3D printed denture teeth offer advantages in durability and functionality compared to conventionally fabricated denture teeth. Results from this study may provide valuable insights into improving the quality and comfort of dentures for edentulous patients.

详细描述

Complete dentures are a common treatment option for edentulous patients, providing essential functionality and aesthetics. With advancements in digital dentistry, 3D printing has emerged as a promising technique for fabricating denture teeth, offering potential benefits such as customization, faster production, and improved material properties. However, the long-term performance of 3D printed denture teeth compared to conventionally fabricated teeth remains under investigation.

This study is designed to assess two critical aspects of denture teeth performance: wear resistance and muscular efficiency. Wear resistance refers to the ability of denture teeth to withstand forces during chewing without significant degradation, while muscular efficiency evaluates how effectively the jaw muscles function with the dentures during activities like chewing and speaking.

The study will recruit completely edentulous patients aged 21-70 years from the Prosthodontics Department at Cairo University. Participants will receive two sets of complete dentures: one fabricated using conventional techniques and the other using 3D printing. The crossover design allows for direct comparison within the same group of patients, minimizing individual variability.

Primary impressions will be taken, followed by the fabrication of dentures using standardized protocols. The amount of wear will be measured by scanning the denture teeth at delivery and after three months of use. Muscular efficiency will be assessed using electromyography (EMG) to measure bite force at delivery and after three months.

This study is self-funded and conducted under the supervision of the Prosthodontics Department at Cairo University. Ethical approval has been obtained, and all participants will provide informed consent. The findings of this study are expected to contribute to the advancement of prosthodontic practices, offering evidence-based recommendations for the use of 3D printed denture teeth in clinical settings.

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
None

入排标准

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

入选标准

  • •Completely edentulous patients. Aged 21-70 years old. Able to read and sign the informed consent document. Class Ι maxilla-mandibular relationship. Free from temporomandibular disorders. Free from systemic diseases that could affect neuromuscular behaviors or muscular activities.
  • •Edentulous condition falls within Class I and II cases based on the Prosthodontic Diagnostic Index (PDI) classification system for complete edentulism.

排除标准

  • •Presence of major medical problems or severe chronic diseases. Poor residual ridge anatomy. Any intra-oral soft or hard tissue abnormalities. Flat, flabby, or knife-edge ridge anatomy.

研究组 & 干预措施

Conventional Denture Teeth

Active Comparator

Participants will receive complete dentures fabricated using conventional techniques with prefabricated acrylic denture teeth.

干预措施: Conventional Denture Teeth (Other)

3D Printed Denture Teeth

Experimental

Participants will receive complete dentures fabricated using 3D printing technology with custom-designed denture teeth.

干预措施: 3D Printed Denture Teeth (Other)

结局指标

主要结局

Amount of Wear

时间窗: 6 months

The amount of wear observed in denture teeth fabricated using conventional techniques versus 3D printing technology. Denture teeth will be scanned at delivery and after 3 months of use, and the wear will be quantified by comparing the scans.

次要结局

  • Muscular Efficiency(6months)

研究者

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

tuqa alazawy

Sponsor-Investigator, Principal Investigator, Prosthodontics Department, Faculty of Dentistry, Cairo University."

Cairo University

相似试验