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临床试验/NCT03413475
NCT03413475已完成不适用

Oral Quality of Life of Patients to be Totally Edentulous at One Arch at Least and Benefiting From the Realization of Immediate and Usual Complete Removable Prostheses.

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年1月4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
59
试验地点
1
主要终点
Geriatric Oral Health Assessment Index (GOHAI) questionnaire

研究概览

简要总结

The restorative and surgical odontological department at the Nantes University Hospital frequently hosts patients with a severely degraded oral condition who has never benefited from a removable prosthetic rehabilitation. The chosen treatment plan consists most of the time in extracting all the residual teeth at one or both arches with the immediate insertion of a complete removable prosthesis performed prior to the extractions. This prosthesis is adapted by regular relining during the osteomucosal healing and is replaced by a usage removable prosthesis on average 6 months after the extractions.

The transition from dentate state (even dilapidated) to toothless state can be a source of discomfort and impairment and lead to a decrease of life's quality for patients. The purpose of this study is to evaluate oral health of the patients at the different stages of prosthetic rehabilitation by using GOHAI (Geriatric Oral Health Assessment Index).

详细描述

Patients are selected at the beginning of their prosthetic rehabilitation and selected patients give their consent for the participation at the clinical trial. The filling of the GOHAI questionnaire is performed in 3 steps:1- before treatment, 2- after teeth extractions and the delivering of immediate complete denture or without immediate prosthetic rehabilitation and 3-during inspection visits after the delivery of the definitive denture.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • An adult man or a woman, speaking and understanding French, benefiting from social security cover.
  • Patient presenting one or more teeth to be extracted, these extractions resulting in a complete uni or bimaxillary edentulism rehabilitated or not by an immediate complete removable prosthesis.

排除标准

  • Patients under the age of majority, patients under protection, protected persons, patients refusing to participate in the study, patients whose follow-up can't be performed, patients who don't speak French and patients who don't benefit from social coverage.
  • Patients rehabilitated by immediate partial removable prosthesis (persistence of teeth on the rehabilitated arch).

结局指标

主要结局

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

时间窗: Month 3

after carrying out the usage prostheses during the inspection visits at 3 months (with a patient carrying his prostheses for at least 1 month).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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