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Completed

NCT Number: NCT04714437

Masticatory Side Change and Masticatory Function.

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.

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Key information

Conditions

Chewing Problem Mastication Disorder

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, University of Barcelona

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

F

Behavioral

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

R

Behavioral

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

L

Behavioral

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

A1

Behavioral

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

A3

Behavioral

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

A5

Behavioral

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Official study title

Relationship Between the Frequency of Masticatory Side Switches and Aspects of Masticatory Function.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2021
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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