To compare the functioning of delayed surgical obturator fabricated using conventional and vacuum formed method in maxillectomy patients: A randomized control study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- CDER
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in obturator functioning
研究概览
简要总结
Surgical obturators are given to maxillectomy patients to help restore the patients eating and speech to near normal levels among other benefits. Conventionally, cold cure/heat cure acrylic resin is used for their fabrication. But patients often complain about unaesthetic display of retentive clasps, compromised retention and leakage of fluid, especially if the defect is large. This study has been designed to fabricate and compare the delayed surgical obturator using vacuum formed thermoplastic sheet with the conventional method in terms of obturator functioning, quality of life and psychological distress as it may be a easier and quicker alternative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Maxillectomy patients indicated for prosthetic rehabilitation.
排除标准
- •Patients with associated midfacial defect Patients with involvement of soft palate, mandible or tongue.
- •Patients with defect of soft palate only Patients not willing to undergo prosthodontic treatment Patients with completely edentulous arches Total bilateral maxillectomy patients.
结局指标
主要结局
Improvement in obturator functioning
时间窗: At 48 hours and 5 weeks after insertion of prosthesis
次要结局
- Improvement in psychological distress and quality of life(Before surgery and one week after surgery; 48 hours after insertion of prosthesis and five weeks after insertion of prosthesis.)