Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124742
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-11-06
Brief Title:
Alteration of Taste Among Orthodontic Patients Following Clear Aligners Treatment
Sponsor:
Riyadh Elm University
Organization:
Riyadh Elm University
Study Overview
Official Title:
Alteration of Taste Among Orthodontic Patients Following Clear Aligners Treatment A Prospective Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 tastes 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
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 tastes 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
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 individuals 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 nd
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 DDS 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 DDS 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 authors 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 DDS 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
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 individuals 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 nd
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 DDS 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 DDS 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 authors 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 DDS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Riyadh Elm University | OTHER | February 2004 | None |