Chewing Problem, Fatigue, Mastication Disorder, Orofacial Pain, Temporomandibular Disorder
Conditions
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.
Interventions
DIAGNOSTIC_TESTFunctional 6-minute mastication 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.
Sponsors
Universitat Internacional de Catalunya
Fundació Universitària del Bages
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Kinesiofobia related to TMD | Before the procedure | Questionnaire TSK-TMD. Score from 12 to 48 points |
| 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) |
| Comorbidities | Before the procedure | Central Sensitization Inventory. Score from 0 to 125 and a checklist |
| Health status | Before the procedure | Patient Health Questionnaire-4 (PHQ-4). Score from 0 to 12. |
| 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? |
| 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 |
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactJordi Padrós-Augé, Mr
Backup ContactArnau Cerdà-Ribó, Mr.
Outcome results
None listed