PEEK Versus Metallic Attachment-retained Obturators Regarding Patient Satisfaction: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- patient satisfaction 1(change" is being assessed)
研究概览
简要总结
Patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment- retained maxillary obturators with metal framework versus milled PEEK framework in the management of maxillectomy cases.
详细描述
Eighteen participants were randomly divided into three parallel groups (n=6). Participants of PEEK group received attachment-retained obturators with milled PEEK framework, metal group received an attachment-retained obturator with metallic framework and conventional group received conventional clasp-retained obturators with metallic framework (Control group). Evaluation included radiographic evaluation and patients' satisfaction where two scales were followed in this study, including "The Obturator Functioning Scale" and "The European Organization for Research and Treatment of Cancer Head and Neck 35" using one way ANOVA test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient underwent surgical removal of half of maxilla
- •participants with a sufficient number of natural teeth(class I and \or class IV Aramany classification) not less than 5 teeth, mouth opening is not less than 25 mm, intact soft palate,
排除标准
- •participants are exposed to radiotherapy or chemotherapy during last year.
- •participant with congenital defect
结局指标
主要结局
patient satisfaction 1(change" is being assessed)
时间窗: 1 week to 6 months
The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"
patient satisfaction 2 (change" is being assessed)
时间窗: 1 week to 6 months
The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is "1"and maximum value is "5"
次要结局
- Radiographic evaluation (change" is being assessed)(base line,6 months, 9 months,12 months)
研究者
Sharaf Mohamed Yahia
Principal Investigator,
Cairo University