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临床试验/NCT05066828
NCT05066828已完成不适用

Patient Satisfaction of Conventional One-piece Versus Two-piece Magnet-retained Obturators for Patients With Complete Edentulism: A Crossover Study

Cairo University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
patient satisfaction

研究概览

简要总结

Evaluation of patients' satisfaction with conventional one-piece obturators versus two pieces magnet -retained obturators in completely edentulous patient maxillectomy cases.

详细描述

Ten completely edentulous participants with hemimaxillectomy (8 males and 2 females) were selected in an across over study. Participants received conventional obturator one piece and two pieces obturator connecting by magnet attachment in alternate periods (sequences A-B and B-A), and outcomes were assessed after 1 week,3 months, and 6 months Evaluation included Obturator Functioning Scale(OFS) and Oral Health Impact Profile for edentulous people (OHIP-EDENT ). One way ANOVA test and Multivariate analysis of variance with a general linear model with repeated measure was used to test the impact of the group, time, and order on each of the studied scores (α=.05).

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 (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • completely edentulous participants with hemimaxillectomy mouth opening is not less than 25 mm and intact soft palate

排除标准

  • exposed to radiotherpy

结局指标

主要结局

patient satisfaction

时间窗: 1 week to 6 months

evaluation of satisfaction by Obturator Functioning Scale(OFS)

次要结局

  • patient satisfaction(1 week to 6 months)

研究者

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

Sharaf Mohamed Yahia

lecturer

Cairo University

研究点 (2)

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