Alteration of Taste Among Orthodontic Patients Following Clear Aligners Treatment

NCT06124742 | Unknown

• 2 other identifiers: FPGRP/2023/722/949/888Riyadh Elm University
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Taste Perception; Orthodontic Appliance Complication; Fixed Orthodontic Appliances

Keywords

Orthodontic Appliance; Taste Perception; clear aligners

Outcome Measures

Primary Outcomes (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.

  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.

Study Arms (1)

clear aligners

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

Device: clear aligners

Interventions

clear aligners DEVICE

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

clear aligners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

Riyadh Elm University

Riyadh, 11681, Saudi Arabia

Location

Related Publications (9)

• 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.

  PMID: 30106421 BACKGROUND

• 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.

  PMID: 9743642 BACKGROUND

• 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.

  PMID: 4525734 BACKGROUND

• 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.

  PMID: 16379166 BACKGROUND

• 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.

  PMID: 34880603 BACKGROUND

• 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.

  PMID: 18274477 BACKGROUND

• 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.

  PMID: 28713117 BACKGROUND

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

  PMID: 15024416 BACKGROUND

• 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.

  PMID: 12677732 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 9, 2023
• Study Start: July 1, 2023
• Primary Completion: January 20, 2024
• Study Completion: February 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-06

Locations

SA (1)