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临床试验/NCT03278041
NCT03278041Unknown不适用

Effect of the Submental Artery Island Flap Versus Maxillary Obturator Prosthesis on the Quality of Life in Patients With Palatal Defects. (Randomized Controlled Clinical Study)

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Quality of life

研究概览

简要总结

The aim of the study is to compare maxillary obturator versus submental artery flap after partial maxillectomy in the aspect of Quality of life outcomes.

详细描述

The maxillary defects created by surgical removal of tumors result in communication between the oral and nasal cavities that in turn impair speech, swallowing, mastication, and facial esthetics, all of which consequently affect social behavior and quality of life (QoL). Consequently, the QoL need to be evaluated in patients with head and neck cancer because surgical resections and associated problems can affect QoL in significant ways.

University of Washington Head and Neck questionnaire is one of the measuring tools of the Quality of life, this UW-QOL questionnaire tests 12 domains relating to the patient with head and neck cancer. The sum score is calculated by adding together the scores for the 12 domains and dividing by 12 for a score from 0 (for poor health) to 100 (good health).

The maxillary defects reconstruction could be approached with prosthetic obturators rehabilitation or through surgical correction.

The obturator prostheses have many advantages that include; the easy visualization of the defect site, which allows for the detection of cancer recurrence; a reduction in the hospitalization period and costs; the ability to avoid a second operation; and the immediate re-establishment of facial morphology and oral functioning.However, several disadvantages to the maxillary obturator exist, including the discomfort of wearing a prosthesis, the inconvenience of removing and cleaning the prosthesis, the inability to successfully retain a prosthesis when the defect is large or when dentition is lacking, and the frequent need for readjustments by a prosthodontist.

The surgical intervention could be with various approaches that provide the reconstruction of communication and yields good results for the reconstruction of small defects.

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
None

盲法说明

Because the two interventions used in this trial are clearly different and easly recognized by the participants and investigators, neither investigator AlAdashi O nor Participants can be blinded.

Similarly, the Assessor (Participants) can't be blinded. The statistician will be blinded.

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All subjects were required:
  • •All patients suffering from midface defects that involving palatal-maxillary bone are included.
  • •All ages and both sexes were included in this study.
  • •Patients with good general condition allowing major surgical procedure under general anesthesia.
  • •Be physically and psychologically able to tolerate procedures.
  • •Be cooperative to return for follow-up, examinations and evaluation.

排除标准

  • •Patient who physically and psychologically not able to tolerate procedures. Because they cannot able to tolerate procedures and may discontinue the follow-up visits.
  • •Be Uncooperative to return for follow-up, examinations and evaluation.
  • •Patients with any systemic disease (e.g uncontrolled diabetic, bisphosphonates .....ect) because that may affect normal healing.
  • •Patient with bad oral hygiene.Because poor oral hygiene can cause inflammation which induces pain that effect outcome reading.

研究组 & 干预措施

surgical reconstruction with submental flap

Experimental

surgical reconstruction with submental flap

干预措施: Submental flap for palatal reconstruction (Procedure)

maxillary obturator

Active Comparator

maxillary obturator

干预措施: maxillary obturator (Device)

结局指标

主要结局

Quality of life

时间窗: one months post operative

measured by University of Washington Head and Neck questionnaire(UW-QOL).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

OMAR ALADASH

Principle Investigator

Cairo University

研究点 (1)

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