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临床试验/NCT04277273
NCT04277273已完成不适用

Descriptive Epidemiological Study of Maxillofacial Prosthesis Consultation at Groupe Hospitalier Pitié-Salpêtrière for Sociodemographic, Medical Characteristics and Quality of Life

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年11月13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
83
试验地点
1
主要终点
Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial Prosthesis

研究概览

简要总结

Patients treated with Maxillofacial Prosthesis have loss of maxillary and/or mandibular substances. Few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics.

详细描述

Patients treated with Maxillofacial Prosthesis have loss of maxillary and/or mandibular substances (oral-nasal or oral-sinusal communication, removal of the soft palate, removal of part of the lower jaw). These losses are mainly due to the surgical consequences of cancers of the upper aerodigestive tract, trauma or sequelae of labio-palate clefts. Depending on the etiology of substance loss, there are 3 main therapeutics: surgical approach, radiotherapy and chemotherapy. The effects of these treatments are functional, aesthetic and psychological. The functions impacted are chewing, phonation, ventilation and swallowing.

Few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics (drug use, type of maxillo-mandibular loss of substance, disorder(s) associated with substance loss, ...).

This study investigates the socio-demographic, medical and quality of life characteristics of Maxillofacial Prosthesis consultation's patients (Department of Dentistry, GHPS) and the potential associations between quality of life and some of these characteristics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Age ≥ 18 years old
  • Patients consulting for Maxillofacial Prosthesis management (Dental Department, Pitié-Salpêtrière Hospital Group)
  • Information and collection of the patient's non-opposition to participation in the research
  • Good written and oral comprehension of the French language

排除标准

  • Under guardianship or curatorship
  • Cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment

结局指标

主要结局

Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial Prosthesis

时间窗: During the consultation (Day 1)

Characteristics such as age, gender, medical history, dental history, oral hygiene will be collected.

次要结局

  • Measurement of overall quality of life: Questionnaire WHOQOL-BREF(During the consultation (Day 1))
  • Measurement of quality of life related to oral health: Questionnaire GOHAI(During the consultation (Day 1))
  • Correlation between quality of life and clinical factors(During the consultation (Day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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