跳至主要内容
临床试验/NCT06103422
NCT06103422已完成不适用

Evaluation of Change in Taste Sense After Orthognathic Surgery

Yağmur Malkoc3 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
3
主要终点
Taste recognition threshold

研究概览

简要总结

Orthognathic surgery refers to jaw operations that can be performed on the upper jaws (Le Fort I osteotomy) and lower jaws (Sagittal Split Ramus osteotomy). In orthognathic surgery practice, taste perception could be affected by potential damage to peripheral nerves that conduct chemosensory information regarding gustation from the palate and tongue. This study aimed to evaluate the changes in the sense of taste after Le Fort I osteotomy, Sagittal Split Ramus osteotomy, and bimaxillary surgery.

详细描述

The subjects were orthognathic surgery patients with facial skeletal deformities who applied to the Department of Oral and Maxillofacial Surgery. Thirty-five patients, aged 17-42 years, gustatory functions were evaluated by administering localized taste tests and whole mouth taste tests preoperatively and at postoperative 1st, 3rd, and 6th months. In the tests, solutions containing sucrose for a sweet taste, sodium chloride for a salty taste, citric acid for a sour taste, and quinine hydrochloride for a bitter taste were used. Patients were compared between the operation group they were in and between operation groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
17 Years 至 42 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • dentofacial deformity
  • American Society of Anesthesiologists category 1 or 2

排除标准

  • zinc, iron, and/or vitamin deficiencies
  • oncological, neurological, endocrinological, and rheumatological diseases
  • chronic drug use due to systemic disease
  • history of chemotherapy and radiotherapy to the head and neck region, orthognathic surgery, maxillofacial trauma, and damage to the nerves related to the taste sensation

结局指标

主要结局

Taste recognition threshold

时间窗: Six months

The solutions were administered in increasing concentrations, starting from the lowest concentration up to the highest concentration until the patient perceived any taste. The lowest concentration at which the patient correctly perceived the administered taste was defined as the "taste recognition threshold. Taste recognition threshold is the primer outcome for whole-mouth taste tests.

Taste intensity rating

时间窗: Six months

The patients were instructed to focus on the perceived taste without closing their mouths and asked to identify the taste and rate the intensity of the taste using a scale ranging between 0 'no taste' and 9 'strongest taste', after each administration. Taste intensity rating is the primer outcome for localized taste tests.

次要结局

未报告次要终点

研究者

发起方
Yağmur Malkoc
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yağmur Malkoc

DDS (Doctor of Dental Surgery)

Istanbul Medipol University Hospital

研究点 (3)

Loading locations...

相似试验