Masticatory Side-switch and Mixing Ability.

NCT05173259 | Completed

• 1 other identifier: HOUB 44/2021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this cross-over intervention study is to assess the effect of masticatory side-switch frequency on different aspects of masticatory function, including masticatory mixing ability and rhythm. A secondary aim is to explore the subjective perception of taste, muscular fatigue, and saliva production through a VAS. Thirty-six volunteers recruited for convenience, among students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona, will perform 6 tests, each consisting of 2 assays, chewing a two-coloured chewing gum, during 40 masticatory cycles. The tests will be randomised masticatory sequences of "free-style", "unilateral-right", "unilateral-left", switching the chewing side at 5% "G05", at 15% "G15" and at 25% "G25". Video recordings of these tests will be made to later assess, on slow playback, the change of the chewing side and the masticatory rhythm. The masticatory mixing ability will be determined through the scanning and posterior analysis of the red-channel in the histogram plug-in in "ImageJ" (R).

Conditions

Chewing Problem; Mastication Disorder

Keywords

Chewing side; Masticatory side-switch; Mastication; Masticatory rhythm; Masticatory performance; Masticatory mixing ability

Outcome Measures

Primary Outcomes (2)

• Masticatory mixing ability

  Masticatory mixing ability will be calculated from the mixing capacity for each type of test (free, right, left and guided). Chewing gum will flattened between two rigid surfaces to a thickness of 1.5 mm. The two sides of the chewing gum will then be scanned at a resolution of 300 dpi. The images will be processed with "ImageJ" with the "Color-Histogram" plugin. Before mixing, the green and red color of the chewing gum are represented in the histogram of the red channel as two separate peaks: one in low intensity and one in high intensity, representing the green and red color of chewing gum, respectively. After mixing, the colors are mixed and so the two peaks merge into one peak. The standard deviation of the intensity distribution is taken as a measure of the mixture of the two colors in the chewing gum. The standard deviation at an early stage of mixing is relatively high, and decreases as the colors are mixed; thus, a high value of the mixing index means a high mixing capacity.

  1 hour

• Side-switch Index

  The number of side switches during the 40 masticatory cycles for each assay will be determined using slow playback of the video recordings of the freestyle mastication test. In the case that this switch is a change of side from left to right or right to left, we will assign a value of "1". If this switch consists of a change from the right or left to central or vice versa, we will assign a value of "0.5". If there is no change of side, the value assigned to this chewing cycle will be "0". To determine the Side-switch Index, the number of side changes will be divided by the maximum number of changes possible during these 5 assays (78).

  1 hour

Secondary Outcomes (4)

• Masticatory Frequency

  1 hour

• Degree of muscular fatigue during this masticatory assay

  1 hour

• Degree of salivary secretion during this masticatory assay

  1 hour

• Degree of taste perception during this masticatory assay

  1 hour

Study Arms (6)

F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence

ACTIVE COMPARATOR

First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F).

Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25

F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence

ACTIVE COMPARATOR

First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G25-G15-G15-G25-G05). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G25-G15-G15-G25-G05). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F).

Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25

F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence

ACTIVE COMPARATOR

First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G05-G25-G25-G05-G15). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F).

Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25

F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence

ACTIVE COMPARATOR

First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G25-G05-G05-G25-G15). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G25-G05-G05-G25-G15). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F).

Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25

F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence

ACTIVE COMPARATOR

First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G05-G15-G15-G05-G25). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G05-G15-G15-G05-G25). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F).

Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25

F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence

ACTIVE COMPARATOR

First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G15-G05-G05-G15-G25). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G15-G05-G05-G15-G25). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F).

Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25

Interventions

F BEHAVIORAL

The participant will be asked to chew the two-coloured chewing gum naturally.

F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence; F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence; F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence; F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence; F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence; F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence

R BEHAVIORAL

The participant will be asked to chew the two-coloured chewing gum on the right-side.

F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence; F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence; F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence; F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence; F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence; F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence

L BEHAVIORAL

The participant will be asked to chew the two-coloured chewing gum on the left-side.

F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence; F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence; F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence; F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence; F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence; F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence

G05 BEHAVIORAL

The participant will be asked to chew the two-coloured chewing gum changing the side in 5%.

F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence; F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence; F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence; F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence; F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence; F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence

G15 BEHAVIORAL

The participant will be asked to chew the two-coloured chewing gum changing the side in 15%.

F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence; F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence; F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence; F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence; F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence; F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence

G25 BEHAVIORAL

The participant will be asked to chew the two-coloured chewing gum changing the side in 25%.

F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence; F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence; F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence; F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence; F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence; F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years old.
• Natural dentition (minimum 24 teeth)

You may not qualify if:

• Active orthodontics treatment.
• Intraoral pain.
• Temporomandibular joint pain.
• Masticatory muscle pain.
• Large dental restorations.
• Dental prosthesis.
• Edentulous spaces.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

School of Dentistry, University of Barcelona

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Related Publications (14)

• van der Bilt A. Assessment of mastication with implications for oral rehabilitation: a review. J Oral Rehabil. 2011 Oct;38(10):754-80. doi: 10.1111/j.1365-2842.2010.02197.x. Epub 2011 Jan 17.

  PMID: 21241351 BACKGROUND

• van der Bilt A, Abbink JH. The influence of food consistency on chewing rate and muscular work. Arch Oral Biol. 2017 Nov;83:105-110. doi: 10.1016/j.archoralbio.2017.07.011. Epub 2017 Jul 20.

  PMID: 28750270 BACKGROUND

• Mizumori T, Tsubakimoto T, Iwasaki M, Nakamura T. Masticatory laterality--evaluation and influence of food texture. J Oral Rehabil. 2003 Oct;30(10):995-9. doi: 10.1046/j.1365-2842.2003.01086.x.

  PMID: 12974859 BACKGROUND

• Flores-Orozco EI, Rovira-Lastra B, Peraire M, Salsench J, Martinez-Gomis J. Reliability of a visual analog scale for determining the preferred mastication side. J Prosthet Dent. 2016 Feb;115(2):203-8. doi: 10.1016/j.prosdent.2015.07.006. Epub 2015 Oct 9.

  PMID: 26455536 BACKGROUND

• Mioche L, Hiiemae KM, Palmer JB. A postero-anterior videofluorographic study of the intra-oral management of food in man. Arch Oral Biol. 2002 Apr;47(4):267-80. doi: 10.1016/s0003-9969(02)00007-9.

  PMID: 11922870 BACKGROUND

• Woda A, Foster K, Mishellany A, Peyron MA. Adaptation of healthy mastication to factors pertaining to the individual or to the food. Physiol Behav. 2006 Aug 30;89(1):28-35. doi: 10.1016/j.physbeh.2006.02.013. Epub 2006 Apr 3.

  PMID: 16581096 BACKGROUND

• Remijn L, Groen BE, Speyer R, van Limbeek J, Nijhuis-van der Sanden MW. Reproducibility of 3D kinematics and surface electromyography measurements of mastication. Physiol Behav. 2016 Mar 1;155:112-21. doi: 10.1016/j.physbeh.2015.11.018. Epub 2015 Nov 23.

  PMID: 26617403 BACKGROUND

• Mizumori T, Arai K. Tsubakimoto T, Yatani H. Chewing side continuity and masticatory performance. Prosthodont Res Pract 2006;5:10-4.

  BACKGROUND

• Weijenberg RA, Scherder EJ, Visscher CM, Gorissen T, Yoshida E, Lobbezoo F. Two-colour chewing gum mixing ability: digitalisation and spatial heterogeneity analysis. J Oral Rehabil. 2013 Oct;40(10):737-43. doi: 10.1111/joor.12090. Epub 2013 Aug 9.

  PMID: 23927753 BACKGROUND

• van der Bilt A, Speksnijder CM, de Liz Pocztaruk R, Abbink JH. Digital image processing versus visual assessment of chewed two-colour wax in mixing ability tests. J Oral Rehabil. 2012 Jan;39(1):11-7. doi: 10.1111/j.1365-2842.2011.02229.x. Epub 2011 Jun 27.

  PMID: 21707695 BACKGROUND

• Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.

  PMID: 26111925 BACKGROUND

• Montero J, Leiva LA, Martin-Quintero I, Barrios-Rodriguez R. Chewing Performance Calculator: An interactive clinical method for quantifying masticatory performance. J Prosthet Dent. 2021 Jan;125(1):82-88. doi: 10.1016/j.prosdent.2019.10.006. Epub 2020 Jan 25.

  PMID: 31987585 BACKGROUND

• Yousof Y, Salleh NM, Yusof F. Quantitative Evaluation of Masticatory Performance with Two-Color Mixing Ability Test: Development of a New Digital Method. Int J Prosthodont. 2020 Mar/Apr;33(2):224-228. doi: 10.11607/ijp.6568.

  PMID: 32069348 BACKGROUND

• van der Bilt A, Mojet J, Tekamp FA, Abbink JH. Comparing masticatory performance and mixing ability. J Oral Rehabil. 2010 Feb;37(2):79-84. doi: 10.1111/j.1365-2842.2009.02040.x. Epub 2009 Dec 7.

  PMID: 19968766 BACKGROUND

MeSH Terms

Interventions

RBM5 protein, human

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor DDS. PhD

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: December 29, 2021
• Study Start: December 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: September 28, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

ES (1)