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临床试验/NCT07740278
NCT07740278招募中不适用

Clinical and Laboratory Assessment of 3D Printing Orientation and Film Thickness on the Accuracy and Patient Satisfaction of Maxillary Complete Dentures

Tanta University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Trueness of 3D-printed maxillary complete denture bases

研究概览

简要总结

This randomized crossover clinical trial aims to evaluate the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients. Each participant will receive two maxillary 3D-printed complete dentures fabricated using the same printing orientation (0°, 45°, or 90°) with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. The study will compare the influence of these printing parameters on denture accuracy and patient-reported outcomes to identify the optimal 3D printing settings for complete denture fabrication.

详细描述

This prospective randomized crossover clinical trial is designed to evaluate and compare the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients.

The study will include completely edentulous patients requiring maxillary and mandibular complete dentures. Each participant will receive two maxillary complete dentures fabricated using 3D printing technology with the same printing orientation but two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. Participants will be randomly allocated to one of three printing orientation groups (0°, 45°, or 90°), with five participants in each group.

The three printing orientations being compared are:

  1. 0° Build Orientation: Maxillary denture bases will be fabricated at a 0° printing orientation using both 50 μm and 100 μm layer thicknesses.
  2. 45° Build Orientation: Maxillary denture bases will be fabricated at a 45° printing orientation using both 50 μm and 100 μm layer thicknesses.
  3. 90° Build Orientation: Maxillary denture bases will be fabricated at a 90° printing orientation using both 50 μm and 100 μm layer thicknesses.

Each participant will wear each denture for a three-month evaluation period. The primary outcomes of the study are trueness of the printed denture bases, assessed by comparing the scanned denture base STL files with the original CAD design, and patient satisfaction, evaluated using a Visual Analogue Scale (VAS) for aesthetics, speech, masticatory efficiency, hygiene, and comfort. Dimensional deviation of the denture bases will also be assessed through three-dimensional superimposition analysis at denture insertion and after three months of use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Completely edentulous patients with good local and systemic health.
  • Patients age ranging from 50 to 70 years old.
  • Patients with adequate inter-arch space.
  • Patients with good neuromuscular control.

排除标准

  • Patients with any oral diseases which may affect denture construction
  • Patients with oral parafunctional habits.
  • Patients with tempro-mandibular disorders

结局指标

主要结局

Trueness of 3D-printed maxillary complete denture bases

时间窗: immedtiate

The trueness of the printed maxillary complete denture bases will be evaluated by comparing the STL file of each scanned denture base with the original CAD design using three-dimensional superimposition analysis.

Patient satisfaction

时间窗: 3 months

Patient satisfaction will be assessed using a 10-point Visual Analogue Scale (VAS) evaluating aesthetics, speech, masticatory efficiency, hygiene, and comfort after wearing each maxillary complete denture.

次要结局

  • Dimensional deviation of 3D-printed maxillary complete denture bases(3 months)

研究者

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

Noha Mamdouh Hamed Elkafoury

assistant lecturer

Tanta University

研究点 (1)

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