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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Temporomandibular Disorder; Chewing Problem; Mastication Disorder; Orofacial Pain
• Intervention / Treatment: Diagnostic test: Functional 6-minute mastication test

• Study Type: Observational
• Enrollment (Estimated): 514

Contacts and Locations

• Study Contact: Name: Jordi Padrós-Augé, Mr; Phone Number: +34613040826; Email: jpadros@umanresa.cat
• Study Contact Backup: Name: Arnau Cerdà-Ribó, Mr.; Phone Number: +34672726921; Email: acerda@umanresa.cat

Study Locations

• Spain
  • Barcelona, Spain, 08017
    • Universitat Internacional de Catalunya
    • Contact: Jordi Tomás-Aliberas, PhD; Phone Number: +34932541800; Email: jtomas@uic.es
  • Barcelona
    • Manresa, Barcelona, Spain, 08242
      • Universitat de Manresa
      • Contact: Jordi Padrós, Mr; Phone Number: 613040826; Email: jpadros@umanresa.cat
      • Principal Investigator: Jordi Padros-Augé, PhDS
      • Principal Investigator: Arnau Cerdà-Ribó, PT
    • Manresa, Barcelona, Spain, 08242
      • Clinica Universitaria UManresa - UViv-UCC, Campus Manresa
      • Principal Investigator: José J Bara Casaus, PhD
      • Contact: Cristian Justribó, Mr; Phone Number: +34672057031; Email: cjustribom@umanresa.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Subjects; Subjects with TMD Screener score < 3	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.; Other Names: TMD-Screener; Diagnostic criteria for temporomandibular disorders (DC/TMD)
TMD subjects; Subjects with TMD screener score ≥ 3	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.; Other Names: TMD-Screener; Diagnostic criteria for temporomandibular disorders (DC/TMD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Fundació Universitària del Bages
• Collaborators: Universitat Internacional de Catalunya

Publications and helpful links

General Publications

• 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.
• Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, Ohrbach R. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011 Oct;142(10):1183-91. doi: 10.14219/jada.archive.2011.0088.
• Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.
• Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.
• Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.
• Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.
• Visscher CM, Lobbezoo F, Naeije M. Comparison of algometry and palpation in the recognition of temporomandibular disorder pain complaints. J Orofac Pain. 2004 Summer;18(3):214-9.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Castroflorio T, Falla D, Tartaglia GM, Sforza C, Deregibus A. Myoelectric manifestations of jaw elevator muscle fatigue and recovery in healthy and TMD subjects. J Oral Rehabil. 2012 Sep;39(9):648-58. doi: 10.1111/j.1365-2842.2012.02309.x. Epub 2012 Apr 10.
• 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.
• van den Engel-Hoek L, Knuijt S, van Gerven MH, Lagarde ML, Groothuis JT, de Groot IJ, Janssen MC. The 6-min mastication test: a unique test to assess endurance of continuous chewing, normal values, reliability, reproducibility and usability in patients with mitochondrial disease. J Oral Rehabil. 2017 Mar;44(3):155-162. doi: 10.1111/joor.12481. Epub 2017 Jan 30.
• Bossuyt PM, Cohen JF, Gatsonis CA, Korevaar DA; STARD group. STARD 2015: updated reporting guidelines for all diagnostic accuracy studies. Ann Transl Med. 2016 Feb;4(4):85. doi: 10.3978/j.issn.2305-5839.2016.02.06. No abstract available.
• González Y, Rivera Y, Espinosa I. Adaptación transcultural de los criterios diagnósticos para la investigación de los trastornos temporomandibulares (CDI/TTM). Rev Fac Odontol Univ Antioq. 2013;25:11-25
• Calixtre LB, Oliveira AB, Alburquerque-Sendin F, Armijo-Olivo S. What is the minimal important difference of pain intensity, mandibular function, and headache impact in patients with temporomandibular disorders? Clinical significance analysis of a randomized controlled trial. Musculoskelet Sci Pract. 2020 Apr;46:102108. doi: 10.1016/j.msksp.2020.102108. Epub 2020 Jan 11.
• Herr K, Spratt KF, Garand L, Li L. Evaluation of the Iowa pain thermometer and other selected pain intensity scales in younger and older adult cohorts using controlled clinical pain: a preliminary study. Pain Med. 2007 Oct-Nov;8(7):585-600. doi: 10.1111/j.1526-4637.2007.00316.x.
• Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
• Other Study ID Numbers: F6MMT_JPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No