Using Flexible Resin in Maxillary Obturators
2016年6月8日 更新者：Damascus University
A Clinical Comparative Study of Two Types of Maxillary Obturators Made of Heat Cure Acrylic Resin or Flexible Resin
Ten patients who had had maxillectomy will be assigned to two groups employing two types of 'temporary obturators. The obturators in the first group will be made from heat cure acrylic resin, whereas those in the second group from flexible resin.
A comparison will be made between the two materials in terms of oral-nasal seal using the drinking water test as well as the mirror test.
研究概览
详细说明
Oral rehabilitation following partial maxillectomy presents numerous clinical and technical issues.
Using soft-tissue undercuts in the palatal side of the upper jaw is so useful for prostheses' retention over and above the abutment teeth.
The use of flexible materials can serve this aim.
The current study aims to compare the efficacy of nasal-oral seal using flexible materials against the traditional method of using heat activated acrylic materials.
研究类型
介入性
注册 (实际的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Damascus、阿拉伯叙利亚共和国、DM20AM18
- Department of removable prosthodontics, University of Damascus Dental School
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 75年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- patient who had partial or complete maxillectomy
- two weeks should have passed at least before being included in the study.
- patient should have completed their radiotherapy.
Exclusion Criteria:
- patients under the age of 10 years
- patients who had had their operations more than five months before the being recruited.
- patients who are under radiotherapy when asked to participate in the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Traditional Obturators
Patients will use traditional obturators which are going to be made from ordinary heat-activated acrylic resin.
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实验性的：Flexible Obturators
Patients will use the new obturators made from flexible resin.
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This material 'Flexible resin' is going to be used in the construction of the 'flexible obturators'.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Amount of leaking water drops from the nose
大体时间：30 minutes following appliance insertion in the mouth
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Each patient is asked to drink an amount of water and keep a specific amount of water in the mouth for two to three minutes.
He/she is asked to rotate his/her head 20-30 degrees downward and forward.
During this period the amount of leaking water drops from the nose is collected and weighted.
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30 minutes following appliance insertion in the mouth
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Amount of air flow through the nose during speech
大体时间：30 minutes following appliance insertion in the mouth
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Each patient is asked to utter the following letters: K, T, D. A cold small mirror is placed in front of the nose during the utterance of these consonants.
If a fogginess is observed on the mirror, this means that there is an oral-nasal leakage of air.
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30 minutes following appliance insertion in the mouth
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Huda Yahia, DDS、MSc student, Removable Prosthodontic Department, University of Damascus Dental School
- 研究主任：Eyad Al-Shaarani, DDS MSc PhD、Professor of Removable Prosthodontics, University of Damascus Dental School
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Aramany MA. Basic principles of obturator design for partially edentulous patients. Part II: Design principles. 1978 [classical article]. J Prosthet Dent. 2001 Dec;86(6):562-8. doi: 10.1067/mpr.2001.121619. No abstract available.
- Grossmann Y, Savion I. The use of a light-polymerized resin-based obturator for the treatment of the maxillofacial patient. J Prosthet Dent. 2005 Sep;94(3):289-92. doi: 10.1016/j.prosdent.2005.06.014.
- MacCarthy D, Murphy N. Replacement of an obturator section of an existing two-piece implant-retained edentulous obturator. J Prosthet Dent. 2000 Jun;83(6):652-5.
- Kanazawa T, Yoshida H, Furuya Y, Shimodaira K. Sectional prosthesis with hollow obturator portion made of thin silicone layer over resin frame. J Oral Rehabil. 2000 Sep;27(9):760-4. doi: 10.1046/j.1365-2842.2000.00584.x.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年5月1日
初级完成 (实际的)
2016年3月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2015年6月23日
首先提交符合 QC 标准的
2015年6月23日
首次发布 (估计)
2015年6月25日
研究记录更新
最后更新发布 (估计)
2016年6月10日
上次提交的符合 QC 标准的更新
2016年6月8日
最后验证
2016年6月1日
更多信息
与本研究相关的术语
其他研究编号
- UDDS-RemPro-01-2015
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.