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| Name | Class |
|---|---|
| Universitat Internacional de Catalunya | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Subjects with TMD Screener score < 3 |
| |
| TMD subjects | Subjects with TMD screener score ≥ 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Score fatigue on a Numerical Rating Scale (0-10). 0 means no fatigue and 10 the highest fatigue possible. | Immediately before the procedure, immediately after the procedure, and five minutes after the procedure |
| Self-reported Pain | Score pain on a Numerical Rating Scale (0-10). 0 means no pain and 10 the highest pain possible | Immediately before the procedure, immediately after the procedure, and five minutes after the procedure |
| Sensitivity and Specificity | Ability to identificate cases vs controls | through study completion, an average of 1 year |
| Feasibity | Intra and inter examinator feasibility | through study completion, an average of 1 year |
| Replicability | Consistency and precision of the test | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Before the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Residents from the Central region of Catalonia and Vallès Occidental, and patients from the University Clinics of the UIC and UVic-UCC, Campus Manresa.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordi Padrós-Augé, Mr | Contact | +34613040826 | jpadros@umanresa.cat | |
| Arnau Cerdà-Ribó, Mr. | Contact | +34672726921 | acerda@umanresa.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universitaria UManresa - UViv-UCC, Campus Manresa | Manresa | Barcelona | 08242 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19092154 | Background | Scrivani SJ, Keith DA, Kaban LB. Temporomandibular disorders. N Engl J Med. 2008 Dec 18;359(25):2693-705. doi: 10.1056/NEJMra0802472. No abstract available. | |
| 6929087 | Background | Sheikholeslam A, Moller E, Lous I. Pain, tenderness and strength of human mandibular elevators. Scand J Dent Res. 1980 Feb;88(1):60-6. doi: 10.1111/j.1600-0722.1980.tb00721.x. |
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| 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?" | Baseline |
| 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 | Immediately before the procedure, immediately after the procedure, and five minutes after the procedure |
| Taste of the gum | Score taste on a Numerical Rating Scale (0-10). 0 means not tasty, and 10 absolutely tasty. | Immediately after the procedure |
| Preferred side when chewing during the F-6MMT | 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. | Immediately after the procedure |
| Kinesiofobia related to TMD | Questionnaire TSK-TMD. Score from 12 to 48 points | Before the procedure |
| Health status | Patient Health Questionnaire-4 (PHQ-4). Score from 0 to 12. | Before the procedure |
| Comorbidities | Central Sensitization Inventory. Score from 0 to 125 and a checklist | Before the procedure |
| Universitat de Manresa | Manresa | Barcelona | 08242 | Spain |
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| Universitat Internacional de Catalunya | Barcelona | 08017 | Spain |
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| 11347660 | Background | Farella M, Bakke M, Michelotti A, Martina R. Effects of prolonged gum chewing on pain and fatigue in human jaw muscles. Eur J Oral Sci. 2001 Apr;109(2):81-5. doi: 10.1034/j.1600-0722.2001.00991.x. |
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| 24063732 | Background | Le Reverend BJ, Edelson LR, Loret C. Anatomical, functional, physiological and behavioural aspects of the development of mastication in early childhood. Br J Nutr. 2014 Feb;111(3):403-14. doi: 10.1017/S0007114513002699. Epub 2013 Sep 24. |
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| 24482784 | Background | Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D013705 | Temporomandibular Joint Disorders |
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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