Clinical trial NCT04714437: Masticatory Side Change and Masticatory Function.
Official title: Relationship Between the Frequency of Masticatory Side Switches and Aspects of Masticatory Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chewing Problem
Mastication Disorder
Keywords: Chewing side
Masticatory side switch
Mastication
Masticatory rhythm
Masticatory performance
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Masticatory performance
timeFrame: 1 hour 30 minutes
measure: Masticatory Frequency
timeFrame: 1 hour 30 minutes
Secondary outcomes:
measure: Side Switch Index
timeFrame: 1 hour 30 minutes
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: School of Dentistry, University of Barcelona
state: Catalonia
Study officials:
References:
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