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NCT Number: NCT06298786

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Universitaria UManresa - UViv-UCC, Campus Manresa, Manresa, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional 6-minute mastication test

Diagnostic Test

All participants will be evaluated in 3 different phases. First, they will respond to the online TMD screener questionnaire. Then, they will be presentally evaluated using the DC/TMD and finally they will undergo the functional 6-minute mastication test.

Other names: TMD-Screener, Diagnostic criteria for temporomandibular disorders (DC/TMD)

Primary outcomes

  1. 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.

  2. 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

  3. Sensitivity and Specificity

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

    Ability to identificate cases vs controls

  4. Feasibity

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

    Intra and inter examinator feasibility

  5. Replicability

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

    Consistency and precision of the test

Secondary outcomes

  1. Pain-related TMD diagnosis

    Time frame: Before the procedure

    All subjects will be classified into the following categories according to the diagnostic criteria for temporomandibular disorders: i) positive TMD (TMD-P), ii) arthralgia (TMD-A), iii) local myalgia (TMD-LM), iv) myofascial pain (TMD-MP), v) headache attributed to TMDs (TMD-HA) or vi) negative TMD (TMD-N)

  2. Self-reported daily fatigue

    Time frame: Baseline

    Dichotomous answers (YES/NO) from the question: "Do you feel tension, heaviness, tiredness, or fatigue of the jaw muscles in any of the daily activities such as chewing, eating, swallowing, smiling, kissing, gesturing, smiling, singing or yawning?"

  3. Pain pressure threshold (PPT)

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

    For measuring PPT a digital algometer (Baoshinshan), with a precision ± 0,2% and a metallic extremity of one cm2 will be used at masseter, anterior temporalis, and forearm of both sides. Scores of the PPT will be measured as Kg/cm^2

  4. Taste of the gum

    Time frame: Immediately after the procedure

    Score taste on a Numerical Rating Scale (0-10). 0 means not tasty, and 10 absolutely tasty.

  5. Preferred side when chewing during the F-6MMT

    Time frame: Immediately after the procedure

    Score how easy was to chew the gum for each side. Numerical Rating Scale (0-10). 0 means preferred left side, 5 means balanced, and 10 preferred right side.

  6. Kinesiofobia related to TMD

    Time frame: Before the procedure

    Questionnaire TSK-TMD. Score from 12 to 48 points

  7. Health status

    Time frame: Before the procedure

    Patient Health Questionnaire-4 (PHQ-4). Score from 0 to 12.

  8. Comorbidities

    Time frame: Before the procedure

    Central Sensitization Inventory. Score from 0 to 125 and a checklist

Study contacts

Contact information is provided by the study sponsor or research team.

Arnau Cerdà-Ribó, Mr.

CONTACT

[email protected]

+34672726921

Jordi Padrós-Augé, Mr

CONTACT

[email protected]

+34613040826

Sponsors and collaborators

Lead sponsor

Fundació Universitària del Bages

Other

Collaborators

  • Universitat Internacional de Catalunya

Registry information

Acronym: F-6MMT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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