Evaluation of Digital Versus Conventional Roofless Obturators in Partial Maxillectomy Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Evaluation of Patient Quality of Life
研究概览
简要总结
Using Digital approach to treat patients with maxillofacial defects without surgical intervention
详细描述
Evaluating digital dental and maxillofacial obturators to artifitially close maxillofacial defects in paients with oral cancer and patients with mucormycosis fungal post covid infection.
Craeting Digitized database for all patients included in the study.
Recording casses with post covid infection in specific period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants in this study will be selected according to the following criteria:
- •Patients with maxillary defects Class I and class II Aramany Classification with completely healed tissues.
- •Patients' age ranging from 20 to 70 years old.
- •Nearly intact mandibular arch.
排除标准
- •Participants with the following criteria will be excluded from the study:
- •Physical or mental instability.
- •Completely edentulous patients.
- •Patients presenting allergy to materials being used.
- •Patients lacking compliance to maintain acceptable oral hygiene.
- •Patients taking radiotherapy
研究组 & 干预措施
digital obturator
new approach to create device
干预措施: obturator (Device)
conventional obturator
old approach to create device
干预措施: obturator (Device)
结局指标
主要结局
Evaluation of Patient Quality of Life
时间窗: six months
questionnaire
Obturator misfit
时间窗: 1 day (at time of device delivery)
descriptive by Digital software
Evaluation of retention
时间窗: 1 day (at time of device insertion)
descriptive by KP scale
Evaluation of hypernasality in speech
时间窗: one month
physiologic parameter
Evaluation of masseter muscle muscle
时间窗: three months
physiologic parameter
次要结局
未报告次要终点
研究者
Eman Nasr
Assistant Lecturer Eman Nasr
Tanta University