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

NCT06298786 | Not Yet Recruiting

• 1 other identifier: F6MMT_JPA
• Study Type: observational
• Target: 514
• Locations: 1 country
• Sites: 3

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.

Conditions

Mastication Disorder; Fatigue; Temporomandibular Disorder; Orofacial Pain; Chewing Problem

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Pain-related TMD diagnosis

  Before the procedure

• Self-reported daily fatigue

  Baseline

• Pain pressure threshold (PPT)

  Immediately before the procedure, immediately after the procedure, and five minutes after the procedure

• Taste of the gum

  Immediately after the procedure

• Preferred side when chewing during the F-6MMT

  Immediately after the procedure

Study Arms (2)

Healthy Subjects

Subjects with TMD Screener score \< 3

Diagnostic Test: Functional 6-minute mastication test

TMD subjects

Subjects with TMD screener score ≥ 3

Diagnostic Test: Functional 6-minute mastication test

Interventions

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.

Also known as: TMD-Screener, Diagnostic criteria for temporomandibular disorders (DC/TMD)

Healthy Subjects; TMD subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Universitària del Bages: lead
• Universitat Internacional de Catalunya: collaborator

Study Sites (3)

Clinica Universitaria UManresa - UViv-UCC, Campus Manresa

Manresa, Barcelona, 08242, Spain

Location

Universitat de Manresa

Manresa, Barcelona, 08242, Spain

Location

Universitat Internacional de Catalunya

Barcelona, 08017, Spain

Location

Related Publications (23)

• 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 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.

  PMID: 6929087 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 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.

  PMID: 11347660 BACKGROUND

• 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.

  PMID: 22490056 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.

  PMID: 24063732 BACKGROUND

• 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.

  PMID: 28054362 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.

  PMID: 24482784 BACKGROUND

• 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.

  PMID: 31689414 BACKGROUND

• 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.

  PMID: 27004232 BACKGROUND

• 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.

  PMID: 21965492 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30586067 BACKGROUND

• 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.

  PMID: 15509000 BACKGROUND

• 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.

  PMID: 31999615 BACKGROUND

• 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.

  PMID: 29321111 BACKGROUND

• 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.

  PMID: 17883743 BACKGROUND

• 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.

  PMID: 15207508 BACKGROUND

• 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.

  PMID: 27330520 BACKGROUND

MeSH Terms

Conditions

Fatigue; Temporomandibular Joint Disorders; Facial Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations

Central Study Contacts

Jordi Padrós-Augé, Mr

CONTACT

+34613040826; jpadros@umanresa.cat

Arnau Cerdà-Ribó, Mr.

CONTACT

+34672726921; acerda@umanresa.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-04

Locations

ES (3)