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Not yet recruiting NCT06298786

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

— Observational Mastication Disorder Fatigue Temporomandibular Disorder Orofacial Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional 6-minute mastication test.
Who it may be relevant to
Registry conditions: Mastication Disorder, Fatigue, Temporomandibular Disorder, Orofacial Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 test 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.

Primary outcome measures

  • Fatigue [Time frame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure]
  • Self-reported Pain [Time frame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure]
  • Sensitivity and Specificity [Time frame: through study completion, an average of 1 year]
  • Feasibity [Time frame: through study completion, an average of 1 year]
  • Replicability [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (8)
  • Pain-related TMD diagnosis [Time frame: Before the procedure]
  • Self-reported daily fatigue [Time frame: Baseline]
  • Pain pressure threshold (PPT) [Time frame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure]
  • Taste of the gum [Time frame: Immediately after the procedure]
  • Preferred side when chewing during the F-6MMT [Time frame: Immediately after the procedure]
  • Kinesiofobia related to TMD [Time frame: Before the procedure]
  • Health status [Time frame: Before the procedure]
  • Comorbidities [Time frame: Before the procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Spain · 3 centers
  • Clinica Universitaria UManresa - UViv-UCC, Campus Manresa — Manresa
  • Universitat de Manresa — Manresa
  • Universitat Internacional de Catalunya — Barcelona

Publications

  • 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. PMID 19092154
  • 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. PMID 6929087
  • Svensson P, Arendt-Nielsen L, Houe L. Muscle pain modulates mastication: an experimental study in humans. J Orofac Pain. 1998 Winter;12(1):7-16. PMID 9656894
  • 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
  • van der Bilt A, Engelen L, Pereira LJ, van der Glas HW, Abbink JH. Oral physiology and mastication. Physiol Behav. 2006 Aug 30;89(1):22-7. doi: 10.1016/j.physbeh.2006.01.025. Epub 2006 Mar 29. PMID 16564557
  • 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

Identifiers

NCT: NCT06298786 · F6MMT_JPA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗