Clinical trial NCT06298786: Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).
Official title: Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mastication Disorder
Fatigue
Temporomandibular Disorder
Orofacial Pain
Chewing Problem
Lead sponsor: Fundació Universitària del Bages
Sponsor class: OTHER
Collaborators: name: Universitat Internacional de Catalunya
First posted: 2024-03-07
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents from the Central region of Catalonia and Vallès Occidental, and patients from the University Clinics of the UIC and UVic-UCC, Campus Manresa.

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 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.


Eligibility criteria: Inclusion Criteria:

* Women and men of legal age
* With or without TMDs symptoms and
* With or without self-reported jaw fatigue when eating

Exclusion Criteria:

* Subjects treated with any type of treatment requiring infiltration of the mandibular region
* Participants undergoing dental interventions in the last 3 months
* Individuals missing two or more teeth in the same quadrant.
* Inability to understand or speak catalan, spanish or english.

Primary outcomes:
measure: Fatigue
timeFrame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure
measure: Self-reported Pain
timeFrame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure
measure: Sensitivity and Specificity
timeFrame: through study completion, an average of 1 year
measure: Feasibity
timeFrame: through study completion, an average of 1 year
measure: Replicability
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Pain-related TMD diagnosis
timeFrame: Before the procedure
measure: Self-reported daily fatigue
timeFrame: Baseline
measure: Pain pressure threshold (PPT)
timeFrame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure
measure: Taste of the gum
timeFrame: Immediately after the procedure
measure: Preferred side when chewing during the F-6MMT
timeFrame: Immediately after the procedure
measure: Kinesiofobia related to TMD
timeFrame: Before the procedure
measure: Health status
timeFrame: Before the procedure
measure: Comorbidities
timeFrame: Before the procedure
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Clinica Universitaria UManresa - UViv-UCC, Campus Manresa
state: Barcelona
city: Manresa
country: Spain
facility: Universitat de Manresa
state: Barcelona
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya
Study officials:
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