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Completed

NCT Number: NCT06989736

Evaluation of Taste Sensation Changes During Fixed Orthodontic Treatment

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.

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Key information

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University Faculty of Dentistry Department of orthodontic

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Taste Test

Diagnostic Test

Participants received nine solutions (tasteless, sweet, salty, sour, and bitter; each in two concentrations) before treatment and six weeks later.

Primary outcomes

  1. Change in Taste Perception Score

    Time frame: 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.

Secondary outcomes

  1. Comparison of Taste Perception Between Treatment and Control Groups

    Time frame: 6 weeks post-treatment

    Evaluation of differences in taste perception scores (VAS) across treatment and control groups after 6 weeks.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

Evaluation of Taste Sensation Changes in Individuals Undergoing Fixed Orthodontic Treatment

Acronym: TASTEFIXED

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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