跳至主要内容
临床试验/NCT03613896
NCT03613896Unknown不适用

Accuracy of 3D Printed Maxillary Complete Dentures Compared With Conventional Complete Dentures: Non-Randomized Control Trial

Cairo University0 个研究点目标入组 13 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
13
主要终点
Accuracy in terms of dimensional changes in denture base

研究概览

简要总结

Conventional complete dentures have been used for almost a century as a treatment choice for edentulous patients, despite of their inaccuracy & dimensional changes during manufacturing. Recently, new manufacturing techniques like RP/3D printing (rapid prototyping) has progressed in the dental field including prosthodontics, does the 3D printed complete denture show more accuracy than conventional ones?

详细描述

Conventional complete dentures have been used as a clinically accepted prosthetic treatment for completely edentulous patients for almost a century. [1] One of its advantages is ability to customize teeth arrangement and to check each step of the preceding steps before the delivery stage.

Conventional complete dentures fabrication consist of several steps of recording, transferring, evaluating, and creating artificial substitutes for patient's teeth and gingiva which must be in harmony with patient's mouth and face. All this steps demand high experience, artistic, and skillful operator and technician.

However denture processing results in polymerization shrinkage of the resin (due to flask cooling), and distortion of the denture base (due to stress release after denture base removal from the stone cast), and decreasing the accuracy and denture adaptation. [2] These dimensional changes increase the gap between the denture base and underlying mucosa, resulting in an ill-fitting denture.[3] Denture adaptation and fitting plays a crucial role in complete denture retention (by physical means), stability, and patient comfort. [4]

Also, flask closure must be done under considerable pressure to ensure metal-to-metal contact between the halves of the flask to confine the resin inside the mold with no excess.[5] In addition to the inherent processing shrinkage and/or expansion properties of the acrylic resin.[6] Researchers tried to overcome these disadvantages by changing the technique of polymerization of the resin, by using of microwave energy, dry heat, and visible light.[7] But unfortunately researchers found that, Discrepancies in the base adaptation shown by several techniques are not easily corrected after complete denture processing.[8] Denture base adaptation to the stone cast is usually not satisfactory, especially in the midline section of the central portion of the posterior border.[9] To overcome the previous disadvantages computer aided manufacturing technology was applied to complete dentures. Some advantages of digitally fabricated complete dentures are 1) reduced number of patient visits; 2) superior strength and fit of dentures; 3) omitting multiple error-introducing steps such as impression, waxing, and casting.[10] 4) reduced cost for patient and clinician; 5) easy denture duplication (due to stored digital data); 6) standardization of clinical research on complete dentures and implant-retained overdentures.

To fabricate physical prototype (model) there are two different approaches: subtractive and additive manufacturing.

研究设计

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

入排标准

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

入选标准

  • Cooperative patients with well developed ridges..

排除标准

  • Pathological changes of residual ridges.
  • Patients with any systemic diseases.
  • Patients with xerostomia.
  • Patients with flabby and flat ridges.
  • Patients with allergy to resins.
  • Patient with sever undercuts, or irregular bony exostosis.

结局指标

主要结局

Accuracy in terms of dimensional changes in denture base

时间窗: immediately after denture construction

we will use radio-opaque markers to measure accuracy on software

次要结局

未报告次要终点

研究者

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

Hadeer mohamed mohamed

Principal Investigator

Cairo University

相似试验