跳至主要内容
临床试验/NCT06989736
NCT06989736已完成不适用

Evaluation of Taste Sensation Changes in Individuals Undergoing Fixed Orthodontic Treatment

Biruni University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Change in Taste Perception Score

研究概览

简要总结

The aim of this study is to determine the changes in taste perception that may occur before and after the initiation of treatment in patients undergoing fixed orthodontic treatment. A total of 128 patients from Biruni University Faculty of Dentistry, Orthodontics Clinic, were randomly selected to either a fixed orthodontic treatment group (n=64) or a control group (n=64), Taste sensation was assessed using nine solutions representing different taste modalities (sweet, salty, sour and bitter), with evaluations conducted via a Visual Analog Scale (VAS) before treatment and six weeks post-treatment. Statistical analyses were performed using the Mann-Whitney U test, Wilcoxon Signed-Rank test and Pearson Chi-Square test. The study found statistically significant differences in sweet taste perception between the first and second sessions in the low-dose experimental group and in bitter taste perception in the high-dose experimental group (p<0.05). However, no statistically significant differences were observed between the experimental and control groups across all taste types and time points (p>0.05). While orthodontic treatment resulted in some changes in sweet and bitter taste perception, no overall significant differences were found between the experimental and control groups. Increased salivary flow rate during treatment and good oral hygiene may help minimize potential effects on taste perception.

详细描述

This interventional clinical study aimed to investigate whether fixed orthodontic treatment affects taste perception in adolescent patients. A total of 128 participants aged 10 to 19 years were recruited and randomly assigned to either a fixed orthodontic treatment group or a control group. Exclusion criteria included systemic diseases, smoking, medications affecting taste, and salivary gland disorders.

Taste perception was assessed using nine standard solutions representing sweet, salty, sour, and bitter tastes at two concentrations each, plus a tasteless solution (distilled water). Evaluations were performed using a Visual Analog Scale (VAS) before treatment and six weeks after treatment initiation.

The study received ethical approval from the Biruni University Interventional Clinical Research Ethics Committee (Decision No: 2015-KAEK-79-23-10). Informed consent was obtained from all participants or their guardians.

Statistical analyses revealed significant intra-group differences in sweet and bitter taste perceptions in the experimental group, while no significant inter-group differences were found across time points. These findings suggest that fixed orthodontic treatment may cause temporary changes in certain taste perceptions, which could be mitigated by increased salivary flow and good oral hygiene practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 10 and 19 years
  • •Applied to the Orthodontics Clinic at Biruni University Faculty of Dentistry
  • •Provided written informed consent (or assent with guardian consent if under 18)
  • •Randomized to either fixed orthodontic treatment or control group

排除标准

  • •Presence of systemic disease
  • •Current smoker
  • •Using medications known to affect taste (e.g., captopril, fluoxetine hydrochloride, sulfadoxine)
  • •Diagnosed with salivary gland disorders
  • •Presence of any pathology that may cause dry mouth (xerostomia)

研究组 & 干预措施

experimental group

Experimental

64 individuals who commenced fixed orthodontic treatment will gargle with the 9 different taste solutions for 15 seconds and then be asked whether they perceive the taste.

干预措施: Taste Test (Diagnostic Test)

Control group

Other

Participants receiving no orthodontic treatment; monitored for taste perception at the same time intervals.

干预措施: Taste Test (Diagnostic Test)

结局指标

主要结局

Change in Taste Perception Score

时间窗: From baseline (pre-treatment) to 6 weeks post-treatment

Taste perception was measured using a Visual Analog Scale (VAS) across four taste modalities (sweet, salty, sour, bitter). VAS scores (0-100) were compared between baseline and 6 weeks post-treatment.

次要结局

  • Comparison of Taste Perception Between Treatment and Control Groups(6 weeks post-treatment)

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sinem Kuru Kaygun

PhD student

Biruni University

研究点 (1)

Loading locations...

相似试验