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临床试验/NCT05044481
NCT05044481已完成不适用

"Impact of the Third Molars in Oral Health-related Quality of Life"

Hospital Carlos Van Buren1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)

研究概览

简要总结

The aim of this study is to evaluate the impact of the third molars in oral health-related quality of life, before and after surgical removal using a validated and frequently used in international investigations instrument (OHIP-14).

详细描述

This is a prospective study that evaluates the oral health-related quality of life through the application of the self-administered OHIP-14 before and after the surgical removal of third molars. The inclusion criteria were adults' patients older than 18 years, referred for oral surgery. Patients with chronic diseases and acute pericoronitis were excluded. The assessment was performed at three times: pre-surgical planning 1 day before surgery (T0), 10 days (T1) and 2 - 3 months after surgery (T2)

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients over 18 years old

排除标准

  • Patients with chronic diseases and acute pericoronitis

结局指标

主要结局

changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)

时间窗: baseline to 10 days and 2 - 3 months after surgery

Short form Oral Health Impact Profile (OHIP-14) was applied at 3 times: baseline, one week before surgery (T1), 10 days after surgery (T2) and 2 - 3 months after surgery (T3). A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM). The Short Form Oral Health Impact Profile (OHIP-14) is an instrument for assessment oral health-related quality of life. 14 ítems values: min = 0 / max = 56 higher scores mean a worse outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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