NCT04714437

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

January 11, 2021

Last Update Submit

May 24, 2022

Conditions

Chewing ProblemMastication Disorder

Keywords

Chewing sideMasticatory side switchMasticationMasticatory rhythmMasticatory performance

Outcome Measures

Primary Outcomes (2)

  • Masticatory performance

    The masticatory performance will be calculated for each test (free, only-right, only-left, and guided tests). The particles from the 5 assays (10g) will be allowed to dry for 24 h. They will then be passed through a series of 8 sieves of different sizes (sizes are: 0.25, 0.425, 0.85, 2, 2.8, 3.15, 4 and 5.6mm). To allow the particles to pass through the sieves, they will be stirred for 6 min. The weight of the remaining pieces of silicone in each sieve will be weighed and the "Median Particle Size" (MPS) will be calculated using the Rosin Rammler formula. The MPS or (X50) is the aperture in mm of a theoretic sieve through which 50% of the weight of the particles would pass, therefore, the smaller the value of MPS, the more masticatory performance the individual has.

    1 hour 30 minutes

  • Masticatory Frequency

    Masticatory frequency will be assessed as the ratio of masticatory cycle number to masticatory time (in cycles per minute).

    1 hour 30 minutes

Secondary Outcomes (1)

  • Side Switch Index

    1 hour 30 minutes

Study Arms (6)

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

ACTIVE COMPARATOR

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)

Behavioral: FBehavioral: RBehavioral: LBehavioral: A1Behavioral: A3Behavioral: A5

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

ACTIVE COMPARATOR

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)

Behavioral: FBehavioral: RBehavioral: LBehavioral: A1Behavioral: A3Behavioral: A5

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

ACTIVE COMPARATOR

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)

Behavioral: FBehavioral: RBehavioral: LBehavioral: A1Behavioral: A3Behavioral: A5

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

ACTIVE COMPARATOR

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)

Behavioral: FBehavioral: RBehavioral: LBehavioral: A1Behavioral: A3Behavioral: A5

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

ACTIVE COMPARATOR

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)

Behavioral: FBehavioral: RBehavioral: LBehavioral: A1Behavioral: A3Behavioral: A5

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

ACTIVE COMPARATOR

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)

Behavioral: FBehavioral: RBehavioral: LBehavioral: A1Behavioral: A3Behavioral: A5

Interventions

FBEHAVIORAL

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

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

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

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

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

F-R/L-A1/A3/A5 SequenceF-R/L-A1/A5/A3 SequenceF-R/L-A3/A1/A5 SequenceF-R/L-A3/A5/A1 SequenceF-R/L-A5/A1/A3 SequenceF-R/L-A5/A3/A1 Sequence
A1BEHAVIORAL

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

F-R/L-A1/A3/A5 SequenceF-R/L-A1/A5/A3 SequenceF-R/L-A3/A1/A5 SequenceF-R/L-A3/A5/A1 SequenceF-R/L-A5/A1/A3 SequenceF-R/L-A5/A3/A1 Sequence
A3BEHAVIORAL

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

F-R/L-A1/A3/A5 SequenceF-R/L-A1/A5/A3 SequenceF-R/L-A3/A1/A5 SequenceF-R/L-A3/A5/A1 SequenceF-R/L-A5/A1/A3 SequenceF-R/L-A5/A3/A1 Sequence
A5BEHAVIORAL

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

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, University of Barcelona

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Related Publications (11)

  • 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.

    PMID: 12791158BACKGROUND

  • 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.

    PMID: 9250840BACKGROUND

  • 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.

    PMID: 20976387BACKGROUND

  • 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.

    PMID: 27494213BACKGROUND

  • 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.

    PMID: 8833593BACKGROUND

  • 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.

    PMID: 29241026BACKGROUND

  • 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: 26617403BACKGROUND

  • 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.

    PMID: 25173664BACKGROUND

  • 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: 11922870BACKGROUND

  • 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.

    PMID: 35107226BACKGROUND

  • 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.

    PMID: 35108409RESULT

Related Links

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

January 11, 2021

First Posted

January 19, 2021

Study Start

February 8, 2021

Primary Completion

March 27, 2021

Study Completion

July 15, 2021

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

ES(1)