Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 1:26 PM
Study NCT ID:
NCT05173259
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masticatory Side-switch and Mixing Ability.
Sponsor:
University of Barcelona
Organization:
Study Overview
Official Title:
Effect of Side Switch Frequency on Masticatory Mixing Ability and Perception of Taste, Muscular Fatigue and Saliva Production: A Randomized Crossover Trial.
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of this cross-over intervention study is to assess the effect of masticatory side-switch frequency on different aspects of masticatory function, including masticatory mixing ability and rhythm. A secondary aim is to explore the subjective perception of taste, muscular fatigue, and saliva production through a VAS. Thirty-six volunteers recruited for convenience, among students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona, will perform 6 tests, each consisting of 2 assays, chewing a two-coloured chewing gum, during 40 masticatory cycles. The tests will be randomised masticatory sequences of "free-style", "unilateral-right", "unilateral-left", switching the chewing side at 5% "G05", at 15% "G15" and at 25% "G25". Video recordings of these tests will be made to later assess, on slow playback, the change of the chewing side and the masticatory rhythm. The masticatory mixing ability will be determined through the scanning and posterior analysis of the red-channel in the histogram plug-in in "ImageJ" (R).
Detailed Description:
This this cross-over intervention study aims to assess the effect of masticatory side-switch frequency on different objective aspects of masticatory function, including masticatory mixing ability and rhythm, as well as the subjective perception of taste, muscular fatigue, and saliva production through a VAS. Each of the thirty-six volunteers recruited for convenience, among students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona, will perform 6 tests, each consisting of 2 assays, chewing a two-coloured chewing gum, during 40 masticatory cycles. One test involves freestyle mastication in which the participant will be asked to masticate the chewing gum. Two tests involve chewing the gum unilaterally (i.e., only on the right-hand side, and only on the left) varying the order of these assays. In the last three tests, the volunteer will switch chewing side in 5% (G05), 15% (G15), or 25% (G25) respectively; the sequence of the assays will be randomized. Twenty-four of these volunteers will be randomly selected to repeat these tests after a period of two weeks. The masticatory mixing ability will be determined through the "mixing capacity index" (MCI), obtained from through the scanning and posterior analysis of the red-channel in the histogram plug-in in "ImageJ" (R), 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: