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Mastication DisorderF-6MMTNCT06298786

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

An observational study of Mastication Disorder and Fatigue, run by Fundació Universitària del Bages at 3 sites in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Functional 6-minute mastication test
How many people
514 participants
Where
3 sitesSpain
Study dates
Sep 2025to Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jordi Padrós-Augé, Mr contact

+34613040826

jpadros@umanresa.cat

Arnau Cerdà-Ribó, Mr. contact

+34672726921

acerda@umanresa.cat

Spain3 sites

  • Universitat Internacional de Catalunya

    Barcelona, 08017

    Jordi Tomás-Aliberas, PhD, +34932541800, jtomas@uic.es

  • Clinica Universitaria UManresa - UViv-UCC, Campus Manresa

    Manresa, Barcelona, 08242

    Cristian Justribó, Mr, +34672057031, cjustribom@umanresa.cat

    José J Bara Casaus, PhD

  • Universitat de Manresa

    Manresa, Barcelona, 08242

    Jordi Padrós, Mr, 613040826, jpadros@umanresa.cat

    Jordi Padros-Augé, PhDS

Other trials in Spain

About this study

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.

Being tested
Functional 6-minute mastication test
Medical subject headings
Fatigue, Temporomandibular Joint Disorders, Facial Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional 6-minute mastication testDiagnostic test

    Also called TMD-Screener, Diagnostic criteria for temporomandibular disorders (DC/TMD)

    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.

Study groups in NCT06298786
Study groupRoleWhat they receive
Healthy SubjectsSubjects with TMD Screener score < 3
Receives: Diagnostic Test: Functional 6-minute mastication test
TMD subjectsSubjects with TMD screener score ≥ 3
Receives: Diagnostic Test: Functional 6-minute mastication test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue

    Score fatigue on a Numerical Rating Scale (0-10). 0 means no fatigue and 10 the highest fatigue possible.

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

  2. Self-reported Pain

    Score pain on a Numerical Rating Scale (0-10). 0 means no pain and 10 the highest pain possible

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

  3. Sensitivity and Specificity

    Ability to identificate cases vs controls

    Measured: through study completion, an average of 1 year

  4. Feasibity

    Intra and inter examinator feasibility

    Measured: through study completion, an average of 1 year

  5. Replicability

    Consistency and precision of the test

    Measured: Through study completion, an average of 1 year

Secondary outcomes (8)

  1. 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)

    Measured: Before the procedure

  2. 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?"

    Measured: Baseline

  3. 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

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

  4. Taste of the gum

    Score taste on a Numerical Rating Scale (0-10). 0 means not tasty, and 10 absolutely tasty.

    Measured: Immediately after the procedure

  5. 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.

    Measured: Immediately after the procedure

  6. Kinesiofobia related to TMD

    Questionnaire TSK-TMD. Score from 12 to 48 points

    Measured: Before the procedure

  7. Health status

    Patient Health Questionnaire-4 (PHQ-4). Score from 0 to 12.

    Measured: Before the procedure

  8. Comorbidities

    Central Sensitization Inventory. Score from 0 to 125 and a checklist

    Measured: Before the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study startSep 2025 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
514 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06298786
Sponsor's protocol ID
F6MMT_JPA
Acronym
F-6MMT
Status last verified
Apr 2025
First submitted
1 Mar 2024
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 11347660

  • 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.

    PubMed 22490056

  • 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.

    PubMed 24063732

  • 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.

    PubMed 28054362

  • 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.

    PubMed 24482784

  • 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.

    PubMed 31689414

  • 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.

    PubMed 27004232

  • 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.

    PubMed 21965492

Questions about this trial

What is this clinical trial studying?

An observational study of Mastication Disorder and Fatigue, run by Fundació Universitària del Bages at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jordi Padrós-Augé, Mr (+34613040826, jpadros@umanresa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue (time frame: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06298786, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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