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Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).

F

Fundació Universitària del Bages

Status

Not yet enrolling

Conditions

Mastication Disorder
Orofacial Pain
Temporomandibular Disorder
Chewing Problem
Fatigue

Treatments

Diagnostic Test: Functional 6-minute mastication test

Study type

Observational

Funder types

Other

Identifiers

NCT06298786
6MIMATE012

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

Healthy Subjects
Description:
Subjects with TMD Screener score \< 3
Treatment:
Diagnostic Test: Functional 6-minute mastication test
TMD subjects
Description:
Subjects with TMD screener score ≥ 3
Treatment:
Diagnostic Test: Functional 6-minute mastication test

Trial contacts and locations

4

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Central trial contact

Jordi Padrós, Mr; Cristian Justribó-Manion, Mr.

Data sourced from clinicaltrials.gov

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