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Taste PerceptionNCT06124742

Alteration of Taste Among Orthodontic Patients Following Clear Aligners Treatment

An observational study of Taste Perception and Orthodontic Appliance Complication, run by Riyadh Elm University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is aimed to assess the gustatory perception and alteration in patients using either clear aligners or fix orthodontics treatment in orthodontic patient aged +18 years and not have any endocrine abnormalities, internal diseases, middle ear affections, xerostomia, or depression. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
clear aligners
Type of treatment
Medical device
How many people
134 participants
Where
1 siteSaudi Arabia
Study dates
1 Jul 2023to 1 Feb 2024
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: It is a prospective cohort study. The study will be carried out at Riyadh Elm university clinic. The investigation will involve 134 participants (aged variety from 15 to 40 years old). A self-administrated questionnaire will be used before and after the orthodontic treatment to assess the taste perception following the clear aligners treatment. In addition, The Burghart taste strips (ODOFIN taste strips) will use clinically to evaluate the taste perceptions.

Who may be able to join

  • Patients in orthodontic therapy using either clear aligners or fixed orthodontic treatment.
  • Healthy patients aged 18 years and over.

Who cannot join

  • endocrine abnormalities (thyroid gland dysfunction, diabetes mellitus, Cushing's disease).
  • internal diseases (chronic renal failure, liver cirrhosis).
  • middle ear affections.
  • xerostomia.
  • depression.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Riyadh Elm University

    Riyadh, 11681

Other trials in Saudi Arabia

About this study

Official title: Alteration of Taste Among Orthodontic Patients Following Clear Aligners Treatment: A Prospective Cohort Study

The goal of this clinical trial is aimed to assess the gustatory perception and alteration in patients using either clear aligners or fix orthodontics treatment in orthodontic patient aged +18 years and not have any endocrine abnormalities, internal diseases, middle ear affections, xerostomia, or depression.

The main question it aims to answer are:

Does the clear aligner have an effect on taste perception following the treatment? Participants will be given a questionnaire before and after the orthodontic treatment to assess the taste perception following the orthodontic treatment. In addition, The Burghart taste strips (ODOFIN taste strips) will clinically assess the taste's function by using four concentrations on three separate occasions (T0, T1, and T2) ,The taste strips will be placed in about the same order; they will apply to the protruding tongue immediately posterior to its first third, either to the left or right side, to study lateralization. subjects will then be asked to close their mouths and choose one of five possible answers on a scale (sweet, sour, salty, bitter, no taste).

Read the detailed description

In Saudi Arabia, one of the common oral health problems is the malocclusion. Crowding was the commonest type of malocclusion followed by increased spacing and overjet (Al-Hummayan, 2018). Malocclusion prevalence varies among different populations globally based on multiple factors including the time of the study, the geographical location. In addition , the selection criteria used for the sample selection, such as age and gender, are all factors that contribute to the malocclusion . Profitt, 2005 reported that 57-59% of Americans had at least some orthodontic treatment needed (Profitt WR, 1998). In the UK, the percentage was 59% (Foster TD, 1974), and in Jordan, it was 92% (Abu Alhaija ES, 2005 ) . There was a report that 40%-62% of Saudi Arabia needed orthodontic treatment (Baseer MA, 2021).

Clear aligner is an alternative to traditional braces that helps to guide the teeth into their proper positions. Unlike braces, clear aligners control tooth movement without metal weirs or brackets. All aligners made of strong plastic materials and made to fit each individual's mouth. the alignment of the teeth can be accomplished using a series of aligners in which each aligner moves the teeth incrementally until the desired result is achieved (Tigani, n.d.).

Orthodontics treatment aims to improve patient quality of life by improving both function and appearance of teeth. So, treatment complications during the treatment plan must be addressed. One of the most important things is proper taste perception. impaired perception of taste stimuli may occur as a result of a foreign body such as placement of the orthodontic material in the oral cavity (Izabella Dunin-Wilczyńska1, 2011).

Through the literature review, many studies were performed on alteration in taste sensation with using removable appliances, and all results were statistically not significant (Hegde AM, 2007) (Sarawan Siripanthana D.D.S., 2015) (Razdan P, 2017). A study analysed the change in taste perception in children using removable orthodontic appliances by using different taste stimuli and asking the children to score as per their perception. There was no statistically significant difference between the study and control groups (Razdan P, 2017). Moreover, a further investigation was conducted on patients who received upper removable orthodontic devices with posterior bite planes, and they used the Modified Harris-Kalmus test to measure the four tastes. salty, sweet, bitter, and sour. this study showed no effect on the taste recognition threshold of the four taste qualities, according to the results of this study (Sarawan Siripanthana D.D.S., 2015). However, alterations of taste perception in orthodontic patients are not studied sufficiently.

Taste is considered a multisensory experience (Shaikh \& Soni., 2022), which contains five senses of taste salty, sour, bitter, sweet, and umami, the last being the Japanese term for a savoury sensation (J., 2004). Gustation loss may arise due to a diverse spectrum of systemic or acute clinical conditions or medications. Moreover, a published article done by otolaryngologists used taste strips, and the results of the study indicate the usefulness of the taste strips in a clinical context (Mueller C, 2003). So based on this article will use the strips which are made from filter paper and impregnated with different taste solutions. taste disturbance can also reduce the pleasure of life and cause a significant reduction in patients' quality of life. It is important, therefore, the main aim of this study to evaluate taste perception following the orthodontics treatment.

To the best of author's knowledge, no study has been published to assess taste perception and taste change after clear aligners treatment. Using clear aligners treatment, the present study aims to assess the effect of taste perception and alteration on taste perception and perception.

Literature review:

Taste perception in orthodontics patients has insufficient studies. There are two studies done on taste perception in patients wearing a removable orthodontic appliance. There are various complaints known related to a removable orthodontic appliance. A study done over 100 volunteers aged between (8-13 years old) to evaluate the complaint regarding appliances and their effect on taste and flavor perception, was divided into two groups (I and II) of 50 children each being divided as study and control groups. Selected volunteers were given samples consisting of eight different taste and flavor stimuli and were asked to score as per their perception in different testing sessions. The overall results revealed that volunteers from both study and control groups, irrespective of the use of removable orthodontic appliances showed marked variation in the estimation of the taste and flavor stimuli in different testing sessions. However, the results obtained were statistically not significant (Hegde AM, 2007).

One short-term study was comparing the recognition of the four taste qualities in Eighteen young patients aged (8-14 years old) wearing upper removable orthodontic appliances with posterior bite planes before and after insertion by using Modified Harris-Kalmus test. The analyses were conducted using SPSS, both Friedman test and Test-retest reliability were used, and the results showed no significant differences (Sarawan Siripanthana D.D.S., 2015).

Another study aimed to analyze the taste perception in 100 young children aged (8- 13 years old) undergoing upper removable orthodontic appliance therapy. the study was divided into two groups (groups I and II) of 50 children each as study and control groups. They used eight different taste stimuli samples consisting of 5 mL samples representing tasteless, sweet, salty, and sour substances. Using verbal score and visual analog scale, the scoring of the volunteers was nearly constant, indicating that an appliance does not play a major role in the alteration of taste stimuli (Razdan P, 2017).

Aim of the research:

The aim of this study is to assess the gustatory perception and alteration in patients using either clear aligners or fix orthodontics treatment.

Specific Objectives:

  • To analyze the complaint regarding clear appliances and their effect on taste and flavor perception.
  • To quantitatively evaluate taste perception by using taste strip.
Being tested
clear aligners
Keywords
Orthodontic Appliance, Taste Perception, clear aligners

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clear alignersDevice

    taste perception will be evaluated before and after using clear aligners.

Study groups in NCT06124742
Study groupRoleWhat they receive
clear alignersThe aim of this study is to assess the gustatory perception and alteration in patients using either clear aligners or fix orthodontics treatment.
Receives: Device: clear aligners

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assess the gustatory perception and alteration in patients using either clear aligners or fix orthodontics treatment.

    • To analyze the complaint regarding clear appliances and their effect on taste and flavor perception. - To quantitatively evaluate taste perception by using taste strip.

    Measured: On three separate occasions, the testing procedures will be carried out. - T0- one month before the appliance is installed. - T1- immediately after appliance installation. - T2- six months after appliance installation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2023
  2. Study start1 Jul 2023
  3. Primary completion20 Jan 2024 (estimated)
  4. Study completion1 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06124742
Sponsor's protocol ID
FPGRP/2023/722/949/888
Other IDs
Riyadh Elm University
Status last verified
Jun 2023
First submitted
6 Nov 2023
Last updated
9 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Alhummayani FM, Taibah SM. Orthodontic treatment needs in Saudi young adults and manpower requirements. Saudi Med J. 2018 Aug;39(8):822-828. doi: 10.15537/smj.2018.8.22337.

    PubMed 30106421
  • Proffit WR, Fields HW Jr, Moray LJ. Prevalence of malocclusion and orthodontic treatment need in the United States: estimates from the NHANES III survey. Int J Adult Orthodon Orthognath Surg. 1998;13(2):97-106.

    PubMed 9743642
  • Foster TD, Day AJ. A survey of malocclusion and the need for orthodontic treatment in a Shropshire school population. Br J Orthod. 1974 Apr;1(3):73-8. doi: 10.1179/bjo.1.3.73. No abstract available.

    PubMed 4525734
  • Abu Alhaija ES, Al-Khateeb SN, Al-Nimri KS. Prevalence of malocclusion in 13-15 year-old North Jordanian school children. Community Dent Health. 2005 Dec;22(4):266-71.

    PubMed 16379166
  • Baseer MA, Almayah NA, Alqahtani KM, Alshaye MI, Aldhahri MM. Oral Impacts Experienced by Orthodontic Patients Undergoing Fixed or Removable Appliances Therapy in Saudi Arabia: A Cross-Sectional Study. Patient Prefer Adherence. 2021 Dec 2;15:2683-2691. doi: 10.2147/PPA.S343084. eCollection 2021.

    PubMed 34880603
  • Hegde AM, Dwivedi S. Effect of removable orthodontic appliance on taste and flavor perception--a clinical study. J Clin Pediatr Dent. 2007 Fall;32(1):79-82. doi: 10.17796/jcpd.32.1.jt1677554845122u.

    PubMed 18274477
  • Razdan P, Sakthivel VS, Naqvi ZA, Goyal V, Tripathi S, Singh S. Alteration in Taste Perception among Young Children during the use of Removable Orthodontic Appliance Therapy. J Contemp Dent Pract. 2017 Jul 1;18(7):607-613. doi: 10.5005/jp-journals-10024-2093.

    PubMed 28713117
  • Bradbury J. Taste perception: cracking the code. PLoS Biol. 2004 Mar;2(3):E64. doi: 10.1371/journal.pbio.0020064. Epub 2004 Mar 16.

    PubMed 15024416
  • Mueller C, Kallert S, Renner B, Stiassny K, Temmel AF, Hummel T, Kobal G. Quantitative assessment of gustatory function in a clinical context using impregnated "taste strips". Rhinology. 2003 Mar;41(1):2-6.

    PubMed 12677732

Questions about this trial

What is this clinical trial studying?

An observational study of Taste Perception and Orthodontic Appliance Complication, run by Riyadh Elm University at 1 site in Saudi Arabia.

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 2 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. 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 Saudi Arabia. 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?

Results are not available in the source record.

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?

assess the gustatory perception and alteration in patients using either clear aligners or fix orthodontics treatment. (time frame: On three separate occasions, the testing procedures will be carried out. - T0- one month before the appliance is installed. - T1- immediately after appliance installation. - T2- six months after appliance installation.). 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 NCT06124742, which also lists 9 linked publications.

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 9 Nov 2023.

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