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临床试验/NCT05585008
NCT05585008已完成不适用

Three Dimensional Printed Versus Conventional Heat Cured Acrylic Complete Denture: An In-Vivo Comparative Study

Suez Canal University1 个研究点 分布在 1 个国家目标入组 20 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
20
试验地点
1
主要终点
retention

研究概览

简要总结

Introduction:

One major complaint frequently voiced by complete denture wearers is denture retention. Conventional denture disadvantage is heat-curing resin deformation. In addition, the pack and press technique that is still more common, residual stresses that occur at the time of packing are released when the material is removed from the flask, causing the resin to shrink, and this shrinkage is cited as a cause of poor fit of the denture base, In the field of prosthetic dentistry, the ability of additive manufacturing to fabricate prosthetic devices based on CAD data influences the overall quality, the mechanical properties of printed parts, the total cost and the manufacturing time. The milling process wastes large quantities of denture base material, and more recent three-dimensional (3D) prototyping promises a more sustainable additive approach by using less denture resin. However, no clinical reports have been published regarding the accuracy of the mucosal surface or denture retention for denture fabricated using conventional techniques compared to those fabricated using additive manufacturing.

Aim of the study:

Investigate the effect of two techniques of complete denture manufacturing (conventional and 3D printed) on denture retention, trueness (accuracy), and satisfaction.

Methodology:

Twenty patients will be selected from the outpatient clinic and will be divided into 2 groups, group A for conventional dentures and group B for 3D printed dentures, retention for the two groups will be measured at 0,1 and 3 months, and patient satisfaction will be recorded, and accuracy of the denture base will be measured on the software. The results will be tabulated and statistically analyzed using the SPSS program.

详细描述

Twenty patients will be selected from the Faculty of Dentistry (Suez Canal University) outpatient clinics with the following criteria:

  • Patients with good neuromuscular control and free of systemic diseases
  • Well-formed ridges with firm and healthy mucosa and no bilateral anterior undercuts.

The patients will be divided equally into two groups(n=10), group (A) which will receive conventional heat cure acrylic denture, and group (B) which will receive 3D printed denture.

Methodology:

A primary impression will be taken for each patient and a special self-cured acrylic tray will be fabricated.

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 (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with good neuromuscular control and free of systemic diseases
  • •the edentulous ridge was covered with healthy firm and dense mucosa
  • •They have upper and lower edentulous healthy alveolar ridges with no remaining roots, no severe bony undercut, or local pathological lesions.
  • •patients had no previous dentures with a nearly equal edentulous period.

排除标准

  • •history of bad habits e.g. severe clenching.
  • •T.M.J disorders
  • •patients with xerostomia, high palatal vault, and short or hyperactive lips were excluded.

研究组 & 干预措施

group A

Active Comparator

group A will receive a conventional heat-cure acrylic denture

干预措施: two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia)) (Device)

group B

Active Comparator

group B will receive a 3D printed complete denture

干预措施: two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia)) (Device)

结局指标

主要结局

retention

时间窗: 3 months

retention will be measured using digital force gauge(weihang electronic gauge,weihang industries, china)

patient satisfaction

时间窗: 3 months

Participants will answer a denture satisfaction questionnaire. Possible answers for each question and respective scores will be: unsatisfactory =0, regular =1, and good =2 (Rehmann et al., 2008)

accuracy of fit (adaptation)

时间窗: 1 week

the deviation of the denture fiitng surface from its corresponding cast will be measured using metrology software (GOM inspect,USA))

次要结局

  • retention over time period(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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