NCT06989736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 13, 2025

Last Update Submit

May 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Taste Perception Score

    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.

    From baseline (pre-treatment) to 6 weeks post-treatment

Secondary Outcomes (1)

  • Comparison of Taste Perception Between Treatment and Control Groups

    6 weeks post-treatment

Study Arms (2)

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.

Diagnostic Test: Taste Test

Control group

OTHER

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

Diagnostic Test: Taste Test

Interventions

Taste TestDIAGNOSTIC_TEST

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

Control groupexperimental group

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University Faculty of Dentistry Department of orthodontic

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Kuru Kaygun S, Konca Tasova FA. Effects of fixed orthodontic treatment on taste perception: a randomized controlled trial. Clin Oral Investig. 2025 Dec 19;30(1):17. doi: 10.1007/s00784-025-06714-6.

MeSH Terms

Conditions

Taste DisordersMalocclusion

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic Diseases

Study Officials

  • Fatma Asli Konca Taşova, DDS, PhD

    Uskudar University Faculty of Dentistry, Department of Orthodontics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 25, 2025

Study Start

September 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 15, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study protocol and ethics committee approval do not include provisions for data sharing

Locations