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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Functional 6-minute mastication test
Diagnostic testAll 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
Trial outcomes
Primary outcomes
Fatigue
Score fatigue on a Numerical Rating Scale (0-10). 0 means no fatigue and 10 the highest fatigue possible.
Self-reported Pain
Score pain on a Numerical Rating Scale (0-10). 0 means no pain and 10 the highest pain possible
Sensitivity and Specificity
Ability to identificate cases vs controls
Feasibity
Intra and inter examinator feasibility
Secondary outcomes
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)
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?"
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
Taste of the gum
Score taste on a Numerical Rating Scale (0-10). 0 means not tasty, and 10 absolutely tasty.
Sponsors and contacts
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Fundació Universitària del Bages
Lead sponsor
Universitat Internacional de Catalunya
Collaborator
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