Viewing Study NCT04714437



Ignite Creation Date: 2024-05-06 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 1:54 PM
Study NCT ID: NCT04714437
Status: COMPLETED
Last Update Posted: 2022-05-27
First Post: 2021-01-11

Brief Title: Masticatory Side Change and Masticatory Function
Sponsor: University of Barcelona
Organization: University of Barcelona

Study Overview

Official Title: Relationship Between the Frequency of Masticatory Side Switches and Aspects of Masticatory Function
Status: COMPLETED
Status Verified Date: 2022-05
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 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 rhythmMasticatory 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 ie 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 Oversight

Has Oversight DMC: None
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?: None