Masticatory Side Change and Masticatory Function.

• ClinicalTrials.gov Identifier: NCT04714437
• Recruitment Status: Completed
• First Posted: January 19, 2021
• Last Update Posted: December 6, 2021
• Sponsor: University of Barcelona
• Information provided by (Responsible Party): Jordi Martinez-Gomis, University of Barcelona

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chewing Problem; Mastication Disorder	Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: A1; Behavioral: A3; Behavioral: A5	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Relationship Between the Frequency of Masticatory Side Switches and Aspects of Masticatory Function.
• Actual Study Start Date: February 8, 2021
• Actual Primary Completion Date: March 27, 2021
• Actual Study Completion Date: July 15, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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)	Behavioral: F; The participant will be asked to chew the latex bag naturally.; Behavioral: R; The participant will be asked to chew the latex bag unilaterally on the right-side.; Behavioral: L; The participant will be asked to chew the latex bag unilaterally on the left-side.; Behavioral: A1; The participant will be asked to chew the latex bag changing the side once.; Behavioral: A3; The participant will be asked to chew the latex bag changing the side three times.; Behavioral: A5; The participant will be asked to chew the latex bag changing the side five times.
Active Comparator: 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)	Behavioral: F; The participant will be asked to chew the latex bag naturally.; Behavioral: R; The participant will be asked to chew the latex bag unilaterally on the right-side.; Behavioral: L; The participant will be asked to chew the latex bag unilaterally on the left-side.; Behavioral: A1; The participant will be asked to chew the latex bag changing the side once.; Behavioral: A3; The participant will be asked to chew the latex bag changing the side three times.; Behavioral: A5; The participant will be asked to chew the latex bag changing the side five times.
Active Comparator: 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)	Behavioral: F; The participant will be asked to chew the latex bag naturally.; Behavioral: R; The participant will be asked to chew the latex bag unilaterally on the right-side.; Behavioral: L; The participant will be asked to chew the latex bag unilaterally on the left-side.; Behavioral: A1; The participant will be asked to chew the latex bag changing the side once.; Behavioral: A3; The participant will be asked to chew the latex bag changing the side three times.; Behavioral: A5; The participant will be asked to chew the latex bag changing the side five times.
Active Comparator: 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)	Behavioral: F; The participant will be asked to chew the latex bag naturally.; Behavioral: R; The participant will be asked to chew the latex bag unilaterally on the right-side.; Behavioral: L; The participant will be asked to chew the latex bag unilaterally on the left-side.; Behavioral: A1; The participant will be asked to chew the latex bag changing the side once.; Behavioral: A3; The participant will be asked to chew the latex bag changing the side three times.; Behavioral: A5; The participant will be asked to chew the latex bag changing the side five times.
Active Comparator: 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)	Behavioral: F; The participant will be asked to chew the latex bag naturally.; Behavioral: R; The participant will be asked to chew the latex bag unilaterally on the right-side.; Behavioral: L; The participant will be asked to chew the latex bag unilaterally on the left-side.; Behavioral: A1; The participant will be asked to chew the latex bag changing the side once.; Behavioral: A3; The participant will be asked to chew the latex bag changing the side three times.; Behavioral: A5; The participant will be asked to chew the latex bag changing the side five times.
Active Comparator: 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)	Behavioral: F; The participant will be asked to chew the latex bag naturally.; Behavioral: R; The participant will be asked to chew the latex bag unilaterally on the right-side.; Behavioral: L; The participant will be asked to chew the latex bag unilaterally on the left-side.; Behavioral: A1; The participant will be asked to chew the latex bag changing the side once.; Behavioral: A3; The participant will be asked to chew the latex bag changing the side three times.; Behavioral: A5; The participant will be asked to chew the latex bag changing the side five times.

Outcome Measures

Primary Outcome Measures :

1. Masticatory performance [ Time Frame: 1 hour 30 minutes ]
   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.
2. Masticatory Frequency [ Time Frame: 1 hour 30 minutes ]
   Masticatory frequency will be assessed as the ratio of masticatory cycle number to masticatory time (in cycles per minute).

Secondary Outcome Measures :

1. Side Switch Index [ Time Frame: 1 hour 30 minutes ]
   The number of side switches during the 20 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 (95).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Spain

School of Dentistry, University of Barcelona

L'Hospitalet De Llobregat, Catalonia, Spain, 08907

Sponsors and Collaborators

University of Barcelona

More Information

Additional Information:

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

Publications:

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.

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.

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.

Flores-Orozco EI, Tiznado-Orozco GE, Osuna-González 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.

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.

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.

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.

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.

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.

• Responsible Party: Jordi Martinez-Gomis, Associate Professor DDS. PhD, University of Barcelona
• ClinicalTrials.gov Identifier: NCT04714437
• Other Study ID Numbers: HOUB 36/2020
• First Posted: January 19, 2021
• Last Update Posted: December 6, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jordi Martinez-Gomis, University of Barcelona:

Chewing side; Masticatory side switch; Mastication; Masticatory rhythm; Masticatory performance