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临床试验/NCT04049058
NCT04049058终止不适用

Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
10
试验地点
1
主要终点
Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively.

研究概览

简要总结

The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment. The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Man and woman ; Age: adolescents (12-17 years) and adults; Specific medical conditions: cleft lip and palate, malocclusion
  • •Non-opposition of the patient
  • •Patient willing to comply with all procedures of the study and its duration

排除标准

  • •Cancellation of orthognathic surgery
  • •Impossibility to receive enlightened information, impossibility to participate in the totality of the study, impossibility to complete only the questionnaire

结局指标

主要结局

Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively.

时间窗: between the preoperative assessment and at 6 months postoperatively.

The OQLQ questionnaire is composed of 22 items that can be rated from 0 to 4. The score varies from 0 to 88. This questionnaire is specific to the evaluation of quality of life in relation to orthognathic surgery.

次要结局

  • Change of OHIP-14 questionnaire score (Oral Health Impact Profile) between preoperative evaluation and at 6 months postoperatively.(between the preoperative assessment and at 6 months postoperatively.)
  • Change of OQLQ (Orthognathic Quality of Life Questionnaire) by type of orthognathic surgery(at 6 months)
  • Change of OHIP-14 (Oral Health Impact Profile) by type of orthognathic surgery(at 6 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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