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Clinical Trials/NCT06298786
NCT06298786
Not Yet Recruiting
N/A

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

Fundació Universitària del Bages3 sites in 1 country514 target enrollmentSeptember 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mastication Disorder
Sponsor
Fundació Universitària del Bages
Enrollment
514
Locations
3
Primary Endpoint
Fatigue
Status
Not Yet Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2025
End Date
April 2026
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundació Universitària del Bages
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Fatigue

Time Frame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure

Score fatigue on a Numerical Rating Scale (0-10). 0 means no fatigue and 10 the highest fatigue possible.

Self-reported Pain

Time Frame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure

Score pain on a Numerical Rating Scale (0-10). 0 means no pain and 10 the highest pain possible

Sensitivity and Specificity

Time Frame: through study completion, an average of 1 year

Ability to identificate cases vs controls

Feasibity

Time Frame: through study completion, an average of 1 year

Intra and inter examinator feasibility

Replicability

Time Frame: Through study completion, an average of 1 year

Consistency and precision of the test

Secondary Outcomes

  • Pain-related TMD diagnosis(Before the procedure)
  • Self-reported daily fatigue(Baseline)
  • Health status(Before the procedure)
  • Pain pressure threshold (PPT)(Immediately before the procedure, immediately after the procedure, and five minutes after the procedure)
  • Preferred side when chewing during the F-6MMT(Immediately after the procedure)
  • Kinesiofobia related to TMD(Before the procedure)
  • Taste of the gum(Immediately after the procedure)
  • Comorbidities(Before the procedure)

Study Sites (3)

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