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

Обзор

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.

Вмешательства

• Диагностический тест Functional 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.

Первичные конечные точки

• Fatigue [Срок оценки: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure]
• Self-reported Pain [Срок оценки: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure]
• Sensitivity and Specificity [Срок оценки: through study completion, an average of 1 year]
• Feasibity [Срок оценки: through study completion, an average of 1 year]
• Replicability [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (8)

• Pain-related TMD diagnosis [Срок оценки: Before the procedure]
• Self-reported daily fatigue [Срок оценки: Baseline]
• Pain pressure threshold (PPT) [Срок оценки: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure]
• Taste of the gum [Срок оценки: Immediately after the procedure]
• Preferred side when chewing during the F-6MMT [Срок оценки: Immediately after the procedure]
• Kinesiofobia related to TMD [Срок оценки: Before the procedure]
• Health status [Срок оценки: Before the procedure]
• Comorbidities [Срок оценки: Before the procedure]

Критерии участия

Критерии включения

• Women and men of legal age
• With or without TMDs symptoms and
• With or without self-reported jaw fatigue when eating

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 3 центра

• Clinica Universitaria UManresa - UViv-UCC, Campus Manresa — Manresa
• Universitat de Manresa — Manresa
• Universitat Internacional de Catalunya — Barcelona

Публикации

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• Wozniak K, Lipski M, Lichota D, Szyszka-Sommerfeld L. Muscle fatigue in the temporal and masseter muscles in patients with temporomandibular dysfunction. Biomed Res Int. 2015;2015:269734. doi: 10.1155/2015/269734. Epub 2015 Mar 26. PMID 25883949
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• Gisel EG. Chewing cycles in 2- to 8-year-old normal children: a developmental profile. Am J Occup Ther. 1988 Jan;42(1):40-6. doi: 10.5014/ajot.42.1.40. PMID 3354628
• Koutris M, Lobbezoo F, Naeije M, Wang K, Svensson P, Arendt-Nielsen L, Farina D. Effects of intense chewing exercises on the masticatory sensory-motor system. J Dent Res. 2009 Jul;88(7):658-62. doi: 10.1177/0022034509338573. PMID 19641154
• 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. PMID 11347660

Идентификаторы

NCT: NCT06298786 · F6MMT_JPA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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