Viewing Study NCT06298786



Ignite Creation Date: 2024-05-06 @ 8:13 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06298786
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-13
First Post: 2024-03-01

Brief Title: Validation and Evaluation of the Mastication Function in Adults The Functional Six-minute Mastication Test F-6MMT
Sponsor: Fundació Universitària del Bages
Organization: Fundació Universitària del Bages

Study Overview

Official Title: Validation and Evaluation of the Mastication Function in Adults The Functional Six-minute Mastication Test F-6MMT
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-02
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: F-6MMT
Brief Summary: Temporomandibular Disorders TMD encompass various conditions that affect the temporomandibular joint and associated tissues often causing or being associated with other symptoms such as jaw pain myofascial pain neck pain and headaches TMDs are classified according to the DCTMD instrument in which the joint and pain axes are evaluated However there is no evaluation of mandibular function and TMDs can result in a decrease in jaw strength and resistance This leads to an increase in the chewing fatigue Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD Chewing efficiency is essential for food preparation and nutrient absorption and muscle fatigue is a common problem affecting chewing ability Despite this there is a lack of validated tests to evaluate chewing fatigue in patients with TMD which makes its consideration unnoticed in clinical practice

The modified six-minute functional chewing test F-6MMT was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated however the subjects were not instructed to perform functional chewing during the test In this version modifications are added so that the test is as functional as possible allowing chewing to be evaluated in a standardized way and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings
Detailed Description: None

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