Taste DisordersTASTEFIXEDNCT06989736
Evaluation of Taste Sensation Changes During Fixed Orthodontic Treatment
A study testing Taste Test in people with Taste Disorders and Orthodontic Appliance Complication, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Taste Disorders, Orthodontic Appliance Complication, Malocclusion
- What is being tested?
- Taste Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni University Faculty of Dentistry Department of orthodontic
Istanbul
About this study
Official title: Evaluation of Taste Sensation Changes in Individuals Undergoing 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.
Read the 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.
- Being tested
- Taste Test
- Medical subject headings
- Taste Disorders, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taste TestDiagnostic test
Participants received nine solutions (tasteless, sweet, salty, sour, and bitter; each in two concentrations) before treatment and six weeks later.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Taste Test |
| Control group | Other | Participants receiving no orthodontic treatment; monitored for taste perception at the same time intervals. Receives: Diagnostic Test: Taste Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (pre-treatment) to 6 weeks post-treatment
Secondary outcomes (1)
Comparison of Taste Perception Between Treatment and Control Groups
Evaluation of differences in taste perception scores (VAS) across treatment and control groups after 6 weeks.
Measured: 6 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Sep 2024
- Primary completion1 Jan 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Taste DisordersStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Kuru Kaygun, Biruni University
- Investigators
- Fatma Asli Konca Taşova, DDS, PhD, Study chair, Uskudar University Faculty of Dentistry, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989736
- Sponsor's protocol ID
- 2015-KAEK-79-23-10
- Acronym
- TASTEFIXED
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study protocol and ethics committee approval do not include provisions for data sharing
Publications
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.
PubMed 41417250
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Taste Sensation Changes in Individuals Undergoing Fixed Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT06989736
- Acronym / sponsor ID
- TASTEFIXED / 2015-KAEK-79-23-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Diagnostic Test: Taste Test64 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. |
| Control group | Other | Diagnostic Test: Taste TestParticipants receiving no orthodontic treatment; monitored for taste perception at the same time intervals. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taste TestParticipants received nine solutions (tasteless, sweet, salty, sour, and bitter; each in two concentrations) before treatment and six weeks later. | Diagnostic test | Control group, experimental group |
Primary outcome
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.
1 secondary outcome
Comparison of Taste Perception Between Treatment and Control Groups
Time frame: 6 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 41417250Kuru 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study protocol and ethics committee approval do not include provisions for data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Asli Konca Taşova, DDS, PhD study chair
Uskudar University Faculty of Dentistry, Department of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taste Test in people with Taste Disorders and Orthodontic Appliance Complication, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Taste Perception Score (time frame: From baseline (pre-treatment) to 6 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06989736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.