Clinical trial NCT06989736: Evaluation of Taste Sensation Changes During Fixed Orthodontic Treatment
Official title: Evaluation of Taste Sensation Changes in Individuals Undergoing Fixed Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Taste Disorders
Orthodontic Appliance Complication
Malocclusion
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 128
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to either a fixed orthodontic treatment group or a no-treatment control group in parallel, and taste perception changes were compared between these groups over time.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Taste Perception Score
timeFrame: From baseline (pre-treatment) to 6 weeks post-treatment
Secondary outcomes:
measure: Comparison of Taste Perception Between Treatment and Control Groups
timeFrame: 6 weeks post-treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University Faculty of Dentistry Department of orthodontic
Study officials:
affiliation: Uskudar University Faculty of Dentistry, Department of Orthodontics
name: Fatma Asli Konca Taşova, DDS, PhD
role: STUDY_CHAIR
References: