protocolSection identificationModule nctId: NCT06298786, orgStudyIdInfo id: 6MIMATE012, briefTitle: Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT)., acronym: F-6MMT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fundació Universitària del Bages, class: OTHER, collaborators name: Hospital Universitari Sagrat Cor, collaborators name: Universitat Internacional de Catalunya, collaborators name: Clinicas Dr. Emilio López Jiménez, descriptionModule briefSummary: 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 DC/TMD 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., conditionsModule conditions: Mastication Disorder, conditions: Fatigue, conditions: Temporomandibular Disorder, conditions: Orofacial Pain, conditions: Chewing Problem, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Functional 6-minute mastication test, outcomesModule primaryOutcomes measure: Fatigue, primaryOutcomes measure: Self-reported Pain, secondaryOutcomes measure: Pain-related TMD diagnosis, secondaryOutcomes measure: Self-reported daily fatigue, secondaryOutcomes measure: Pain pressure threshold (PPT), secondaryOutcomes measure: Taste of the gum, secondaryOutcomes measure: Difficulty in breaking the gum at the beginning of the F-6MMT, secondaryOutcomes measure: Preferred side when chewing during the F-6MMT, secondaryOutcomes measure: Kinesiofobia related to TMD, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Comorbidities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitat de Manresa, city: Manresa, state: Barcelona, zip: 08242, country: Spain, contacts name: Jordi Padrós, Mr, role: CONTACT, phone: 613040826, email: jpadros@umanresa.cat, contacts name: Jordi Padros-Augé, PhDS, role: PRINCIPAL_INVESTIGATOR, contacts name: Arnau Cerdà-Ribó, PT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.72815, lon: 1.82399, locations facility: Universitat Internacional de Catalunya, city: Barcelona, zip: 08017, country: Spain, contacts name: Jordi Tomás-Aliberas, PhD, role: CONTACT, phone: +34932541800, email: jtomas@uic.es, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital QuirónSalud Sagrado Corazón, city: Barcelona, zip: 08029, country: Spain, contacts name: Cristian Justribó, Mr, role: CONTACT, phone: +34672057031, email: cjustribom@uao.es, contacts name: Cristian Justribó-Manion, PhDS, role: PRINCIPAL_INVESTIGATOR, contacts name: José J Bara Casaus, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Clínicas Dr. Emilio López Jiménez, city: Jaén, zip: 23280, country: Spain, contacts name: Emilio López-Jiménez, PhD, role: CONTACT, phone: 665842389, email: ddnariz@gmail.com, geoPoint lat: 37.76922, lon: -3.79028, hasResults: False