Masticatory Side-switch and Mixing Ability.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-09-28

Brief Summary

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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).

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Detailed Description

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This this cross-over intervention study aims to assess the effect of masticatory side-switch frequency on different objective aspects of masticatory function, including masticatory mixing ability and rhythm, as well as the subjective perception of taste, muscular fatigue, and saliva production through a VAS. Each of the 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. One test involves freestyle mastication in which the participant will be asked to masticate the chewing gum. Two tests involve chewing the gum unilaterally (i.e., only on the right-hand side, and only on the left) varying the order of these assays. In the last three tests, the volunteer will switch chewing side in 5% (G05), 15% (G15), or 25% (G25) respectively; the sequence of the assays will be randomized. Twenty-four of these volunteers will be randomly selected to repeat these tests after a period of two weeks. The masticatory mixing ability will be determined through the "mixing capacity index" (MCI), obtained from through the scanning and posterior analysis of the red-channel in the histogram plug-in in "ImageJ" (R), and the masticatory rhythm will be assessed through the masticatory frequency as the ratio of masticatory cycle number to masticatory time. The control variables will include age and sex.

Conditions

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Chewing Problem Mastication Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

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).

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

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

R

Intervention Type BEHAVIORAL

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

L

Intervention Type BEHAVIORAL

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

G05

Intervention Type BEHAVIORAL

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

G15

Intervention Type BEHAVIORAL

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

G25

Intervention Type BEHAVIORAL

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

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

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).

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

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

R

Intervention Type BEHAVIORAL

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

L

Intervention Type BEHAVIORAL

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

G05

Intervention Type BEHAVIORAL

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

G15

Intervention Type BEHAVIORAL

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

G25

Intervention Type BEHAVIORAL

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

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

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).

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

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

R

Intervention Type BEHAVIORAL

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

L

Intervention Type BEHAVIORAL

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

G05

Intervention Type BEHAVIORAL

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

G15

Intervention Type BEHAVIORAL

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

G25

Intervention Type BEHAVIORAL

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

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

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).

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

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

R

Intervention Type BEHAVIORAL

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

L

Intervention Type BEHAVIORAL

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

G05

Intervention Type BEHAVIORAL

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

G15

Intervention Type BEHAVIORAL

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

G25

Intervention Type BEHAVIORAL

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

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

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).

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

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

R

Intervention Type BEHAVIORAL

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

L

Intervention Type BEHAVIORAL

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

G05

Intervention Type BEHAVIORAL

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

G15

Intervention Type BEHAVIORAL

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

G25

Intervention Type BEHAVIORAL

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

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

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).

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

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

R

Intervention Type BEHAVIORAL

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

L

Intervention Type BEHAVIORAL

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

G05

Intervention Type BEHAVIORAL

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

G15

Intervention Type BEHAVIORAL

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

G25

Intervention Type BEHAVIORAL

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

Interventions

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F

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

Intervention Type BEHAVIORAL

R

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

Intervention Type BEHAVIORAL

L

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

Intervention Type BEHAVIORAL

G05

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

Intervention Type BEHAVIORAL

G15

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

Intervention Type BEHAVIORAL

G25

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Jordi Martinez-Gomis

Associate Professor DDS. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Dentistry, University of Barcelona

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND

PMID: 21241351 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 28750270 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12974859 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 26455536 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11922870 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16581096 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 26617403 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND

PMID: 23927753 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 21707695 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 26111925 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 31987585 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32069348 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19968766 (View on PubMed)

Other Identifiers

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HOUB 44/2021

Identifier Type: -

Identifier Source: org_study_id

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Masticatory Side-switch and Mixing Ability.

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Orofacial Functions and Masticatory Function in Children With Different Types of Deterioration in Oral Health

Masticatory Efficiency in Children

The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test

Assessing Fatiguability of Tongue Muscles in MS

Salivary Flow Rate and Oral Function

Detailed Description

Conditions

Study Design

Study Groups

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

F

R

L

G05

G15

G25

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

F

R

L

G05

G15

G25

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

F

R

L

G05

G15

G25

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

F

R

L

G05

G15

G25

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

F

R

L

G05

G15

G25

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

F

R

L

G05

G15

G25

Interventions

F

R

L

G05

G15

G25

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

University of Barcelona

Responsible Party

Jordi Martinez-Gomis

Locations

School of Dentistry, University of Barcelona

Countries

References

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.

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.

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.

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.

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.

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.