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

Not yet recruiting

• Conditions: Orofacial Pain; Mastication Disorder; Fatigue; Temporomandibular Disorder; Chewing Problem

• Registration Number: NCT06298786
• Lead Sponsor: Fundació Universitària del Bages

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2025-09
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 514

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue	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	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	through study completion, an average of 1 year	Ability to identificate cases vs controls
Feasibity	through study completion, an average of 1 year	Intra and inter examinator feasibility
Replicability	Through study completion, an average of 1 year	Consistency and precision of the test

Secondary Outcome Measures

Name	Time	Method
Pain-related TMD diagnosis	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)
Self-reported daily fatigue	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?"
Health status	Before the procedure	Patient Health Questionnaire-4 (PHQ-4). Score from 0 to 12.
Pain pressure threshold (PPT)	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
Preferred side when chewing during the F-6MMT	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.
Kinesiofobia related to TMD	Before the procedure	Questionnaire TSK-TMD. Score from 12 to 48 points
Comorbidities	Before the procedure	Central Sensitization Inventory. Score from 0 to 125 and a checklist
Taste of the gum	Immediately after the procedure	Score taste on a Numerical Rating Scale (0-10). 0 means not tasty, and 10 absolutely tasty.

Trial Locations

Locations (3)

Clinica Universitaria UManresa - UViv-UCC, Campus Manresa; 🇪🇸 Manresa, Barcelona, Spain

Universitat de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Universitat Internacional de Catalunya; 🇪🇸 Barcelona, Spain