跳至主要内容
临床试验/NCT06588140
NCT06588140已完成不适用

Comparison of Retention Between Different Duplication Techniques of Complete Dentures: Conventional Versus CAD/CAM: A Within Subject Controlled Clinical Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9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
Assessment of Retention of maxillary complete denture

研究概览

简要总结

Twenty completely edentulous patients with old, removable dentures with ill-fitting maxillary dentures, proper vertical dimension, and proper occlusion will be recruited for this trial. They will be rehabilitated with duplicated complete dentures manufactured by conventional and two different 3D-printed CAD-CAM Complete Removable Dentures techniques.

Outcomes will be evaluated, including denture retention, which will be evaluated using a digital force gauge, and occlusal force distribution by using a t-scan.

详细描述

The study will be conducted at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. This within-subject controlled clinical trial will involve twenty completely edentulous patients with old, ill-fitting maxillary complete dentures, who will be selected and recruited following approval by the Research Ethics Committee of the Faculty of Dentistry, Ain Shams University (FDASU-REC). These patients will be rehabilitated with duplicated complete dentures produced through conventional methods and two distinct 3D-printed CAD/CAM techniques.

Group I: The duplication of a refitted complete removable denture will be performed using the conventional heat-cured technique.

Group II: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, where the denture base will be printed separately with pink resin, and the teeth will be printed as a single unit in tooth-colored resin, followed by assembly of the two components.

Group III: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, with the entire denture printed as a single unit in tooth-colored resin, and the denture flange veneered with pink resin.

Outcomes will be evaluated by measuring denture retention with a digital force gauge and occlusal force distribution using the T-Scan system. The collected data will be recorded, tabulated, and subjected to statistical analysis using appropriate tests for group comparisons.

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 (Participant)

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
是

入选标准

  • •Patients with old complete dentures without lost vertical dimension.
  • •Patients with correct centric occluding relation.
  • •The dentures should be esthetically and functionally satisfactory and exhibit reasonable retention and stability

排除标准

  • •The presence of ridge or soft tissue pathology.
  • •Diminished saliva production.
  • •A history of medications affecting saliva quantity or quality.
  • •Patients with temporomandibular joint problems.
  • •The presence of sever ridge undercut.
  • •Debilitated patients

研究组 & 干预措施

conventional heat-cured duplication technique.

Active Comparator

Duplication of refitted complete removable dentures by conventional heat-cured technique from heat-cured polymethyl methacrylate resin.

干预措施: Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate. (Device)

3d Printed CAD/CAM duplication technique from Pink polymethyl methacrylate base resin

Experimental

Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture base will be printed separately using pink base polymethyl methacrylate resin, and the teeth will be printed as one unit using tooth-colored resin, followed by assembling the two components.

干预措施: Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin. (Device)

3d Printed CAD/CAM duplication technique from white polymethyl methacrylate base resin

Experimental

Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture will be printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink resin.

干预措施: Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin. (Device)

结局指标

主要结局

Assessment of Retention of maxillary complete denture

时间窗: at the time of denture insertion

The retention of a maxillary complete denture will be assessed using a digital force gauge meter, with retention measurements recorded in Newtons.

次要结局

  • Evaluation of occlusal force distribution between right and left side(at the time of denture insertion)

研究者

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

Omnia M. Refai

Lecturer of Oral and Maxillofacial Prosthodontics

Ain Shams University

研究点 (1)

Loading locations...

相似试验