Masticatory Side Change and Masticatory Function.

NCT ID: NCT04714437

Last Updated: 2022-05-27

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2021-07-15

Brief Summary

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The primary objective of this study is to establish the effect of the frequency of masticatory side switches on masticatory performance. We also want to know the effect of the frequency of masticatory side switches on the masticatory rhythm. Twenty-eight healthy volunteers will undertake masticatory tests, following a series of instructions given at the moment. These volunteers will take a re-test in two-weeks time. The sequence of these tests will be randomized in such a way that, each participant will initially perform an established sequence of "freestyle, only-right, and only-left" masticatory tests, and then will carry out one of the 6 possible combinations of "A1, A3, and A5". These tests will be recorded on video to assess, on slow playback, the change of the chewing side, and the masticatory rhythm.Masticatory performance will be determined by sieving the silicone particles.

Detailed Description

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This crossover intervention study aims to assess the effect of the degree of alternance of the chewing side on various aspects of masticatory function, including masticatory performance and rhythm. Twenty-eight volunteers will take part, recruited for convenience, among friends and relatives of the teachers and students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona. These individuals will perform masticatory tests and, after a period of two weeks, will repeat them as a re-test. Each participant will perform 6 tests, each consisting of 5 assays, chewing a small latex bag containing a few silicone tablets (2 g) during 20 masticatory cycles. One test involves freestyle mastication in which the participant will be asked to chew the latex bag naturally. Two tests involve chewing the bag unilaterally (i.e., right-hand side in one and left-hand side in the other) and the order of their assays will be varied. For the last three tests, the participant will change the chewing side 1 (A1), 3 (A3), or 5 (A5) times respectively; the sequence of the assays will be randomized. The masticatory performance will be determined by the "median particle size" (MPS), 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-A1/A3/A5 Sequence

First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A1-A3-A5-A5-A3-A1-A1-A3-A5-A5-A3-A1-A1-A3-A5)

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag naturally.

R

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the right-side.

L

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the left-side.

A1

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side once.

A3

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side three times.

A5

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side five times.

F-R/L-A1/A5/A3 Sequence

First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A1-A5-A3-A3-A5-A1-A1-A5-A3-A3-A5-A1-A1-A5-A3)

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag naturally.

R

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the right-side.

L

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the left-side.

A1

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side once.

A3

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side three times.

A5

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side five times.

F-R/L-A3/A1/A5 Sequence

First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A3-A1-A5-A5-A1-A3-A3-A1-A5-A5-A1-A3-A3-A1-A5)

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag naturally.

R

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the right-side.

L

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the left-side.

A1

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side once.

A3

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side three times.

A5

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side five times.

F-R/L-A3/A5/A1 Sequence

First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A3-A5-A1-A1-A5-A3-A3-A5-A1-A1-A5-A3-A3-A5-A1)

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag naturally.

R

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the right-side.

L

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the left-side.

A1

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side once.

A3

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side three times.

A5

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side five times.

F-R/L-A5/A1/A3 Sequence

First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A5-A1-A3-A3-A1-A5-A5-A1-A3-A3-A1-A5-A5-A1-A3)

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag naturally.

R

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the right-side.

L

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the left-side.

A1

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side once.

A3

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side three times.

A5

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side five times.

F-R/L-A5/A3/A1 Sequence

First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A5-A3-A1-A1-A3-A5-A5-A3-A1-A1-A3-A5-A5-A3-A1)

Group Type ACTIVE_COMPARATOR

F

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag naturally.

R

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the right-side.

L

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag unilaterally on the left-side.

A1

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side once.

A3

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side three times.

A5

Intervention Type BEHAVIORAL

The participant will be asked to chew the latex bag changing the side five times.

Interventions

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F

The participant will be asked to chew the latex bag naturally.

Intervention Type BEHAVIORAL

R

The participant will be asked to chew the latex bag unilaterally on the right-side.

Intervention Type BEHAVIORAL

L

The participant will be asked to chew the latex bag unilaterally on the left-side.

Intervention Type BEHAVIORAL

A1

The participant will be asked to chew the latex bag changing the side once.

Intervention Type BEHAVIORAL

A3

The participant will be asked to chew the latex bag changing the side three times.

Intervention Type BEHAVIORAL

A5

The participant will be asked to chew the latex bag changing the side five times.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Barcelona

OTHER

Sponsor Role lead

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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Albert TE, Buschang PH, Throckmorton GS. Masticatory performance: a protocol for standardized production of an artificial test food. J Oral Rehabil. 2003 Jul;30(7):720-2. doi: 10.1046/j.1365-2842.2003.01155.x.

Reference Type BACKGROUND
PMID: 12791158 (View on PubMed)

Buschang PH, Throckmorton GS, Travers KH, Johnson G. The effects of bolus size and chewing rate on masticatory performance with artificial test foods. J Oral Rehabil. 1997 Jul;24(7):522-6. doi: 10.1046/j.1365-2842.1997.00524.x.

Reference Type BACKGROUND
PMID: 9250840 (View on PubMed)

Farias Gomes SG, Custodio W, Moura Jufer JS, Del Bel Cury AA, Rodrigues Garcia RC. Correlation of mastication and masticatory movements and effect of chewing side preference. Braz Dent J. 2010;21(4):351-5. doi: 10.1590/s0103-64402010000400011.

Reference Type BACKGROUND
PMID: 20976387 (View on PubMed)

Flores-Orozco EI, Tiznado-Orozco GE, Osuna-Gonzalez OD, Amaro-Navarrete CL, Rovira-Lastra B, Martinez-Gomis J. Lack of relationship between masticatory performance and nutritional status in adults with natural dentition. Arch Oral Biol. 2016 Nov;71:117-121. doi: 10.1016/j.archoralbio.2016.07.008. Epub 2016 Jul 29.

Reference Type BACKGROUND
PMID: 27494213 (View on PubMed)

Julien KC, Buschang PH, Throckmorton GS, Dechow PC. Normal masticatory performance in young adults and children. Arch Oral Biol. 1996 Jan;41(1):69-75. doi: 10.1016/0003-9969(95)00098-4.

Reference Type BACKGROUND
PMID: 8833593 (View on PubMed)

Khoury-Ribas L, Ayuso-Montero R, Rovira-Lastra B, Peraire M, Martinez-Gomis J. Reliability of a new test food to assess masticatory function. Arch Oral Biol. 2018 Mar;87:1-6. doi: 10.1016/j.archoralbio.2017.12.006. Epub 2017 Dec 9.

Reference Type BACKGROUND
PMID: 29241026 (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)

Rovira-Lastra B, Flores-Orozco EI, Salsench J, Peraire M, Martinez-Gomis J. Is the side with the best masticatory performance selected for chewing? Arch Oral Biol. 2014 Dec;59(12):1316-20. doi: 10.1016/j.archoralbio.2014.08.005. Epub 2014 Aug 18.

Reference Type BACKGROUND
PMID: 25173664 (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)

Khoury-Ribas L, Ignatova-Mishutina T, Rovira-Lastra B, Ayuso-Montero R, Martinez-Gomis J. Impact of Treatment with Unilateral Implant- Supported Fixed Partial Prosthesis on the Frequency of Masticatory Side Switches in Patients with Unilateral Posterior Missing Teeth. Eur J Prosthodont Restor Dent. 2022 Nov 30;30(4):245-251. doi: 10.1922/EJPRD_2336Khoury-Ribas07.

Reference Type BACKGROUND
PMID: 35107226 (View on PubMed)

Ignatova-Mishutina T, Khoury-Ribas L, Flores-Orozco EI, Rovira-Lastra B, Martinez-Gomis J. Effect of side switch frequency on masticatory performance and rhythm in adults with natural dentition: A randomised crossover trial. J Oral Rehabil. 2022 Apr;49(4):373-380. doi: 10.1111/joor.13308. Epub 2022 Feb 12.

Reference Type RESULT
PMID: 35108409 (View on PubMed)

Related Links

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https://doi.org/10.2186/prp.5.10

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

Other Identifiers

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HOUB 36/2020

Identifier Type: -

Identifier Source: org_study_id

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