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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundació Universitària del Bages

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Women and men of legal age

With or without TMDs symptoms and

With or without self-reported jaw fatigue when eating

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

514 Participants
are divided into 2 treatment groups
Group A: Healthy Subjects1 intervention
Group B: TMD subjects1 intervention

Trial outcomes

Primary outcomes

1

Fatigue

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

Time frame
Immediately before the procedure, immediately after the procedure, and five minutes after the procedure
2

Self-reported Pain

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

Time frame
Immediately before the procedure, immediately after the procedure, and five minutes after the procedure
3

Sensitivity and Specificity

Ability to identificate cases vs controls

Time frame
through study completion, an average of 1 year
4

Feasibity

Intra and inter examinator feasibility

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Pain-related TMD diagnosis

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)

Time frame
Before the procedure
2

Self-reported daily fatigue

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?"

Time frame
Baseline
3

Pain pressure threshold (PPT)

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

Time frame
Immediately before the procedure, immediately after the procedure, and five minutes after the procedure
4

Taste of the gum

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

Time frame
Immediately after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundació Universitària del Bages

Lead sponsor

Universitat Internacional de Catalunya

Collaborator

This trial is not recruiting at the moment. You can still explore other options: