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

Fatigue Clinical Trial

— F-6MMT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298786
• Other study ID #: 6MIMATE012
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Fundació Universitària del Bages
• Contact: Jordi Padrós, Mr
• Phone: +34613040826
• Email: jpadros[@]umanresa.cat
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chewing Problem
• Facial Pain
• Fatigue
• Mastication Disorder
• Orofacial Pain
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital QuirónSalud Sagrado Corazón	Barcelona
Spain	Universitat Internacional de Catalunya	Barcelona
Spain	Clínicas Dr. Emilio López Jiménez	Jaén
Spain	Universitat de Manresa	Manresa	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Fundació Universitària del Bages	Clinicas Dr. Emilio López Jiménez, Hospital Universitari Sagrat Cor, Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (23)

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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. — View Citation

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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

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. — View Citation

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. — View Citation

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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. Erratum In: J Chiropr Med. 2017 Dec;16(4):346. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Score fatigue on a Numerical Rating Scale (0-10). 0 means no fatigue and 10 the highest fatigue possible.	Immediately before the 6MMT, immediately after the F-6MMT, and five minutes after the F-6MMT
Primary	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 6MMT, immediately after the F-6MMT, and five minutes after the F-6MMT
Secondary	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 F-6MMT.
Secondary	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?"	Before F-6MMT
Secondary	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 6MMT, immediately after the F-6MMT, and five minutes after the F-6MMT
Secondary	Taste of the gum	Score taste on a Numerical Rating Scale (0-10). 0 means not tasty, and 10 absolutely tasty.	In between the five minutes immediately after the test and before the assessment of the fatigue and pain after the test.
Secondary	Difficulty in breaking the gum at the beginning of the F-6MMT	Score how difficult was to break the gum at the beginning of the test on a Numerical Rating Scale (0-10). 0 means not difficult at all, and 10 impossible to break.	In between the five minutes immediately after the test and before the assessment of the fatigue and pain after the test.
Secondary	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.	In between the five minutes immediately after the test and before the assessment of the fatigue and pain after the test.
Secondary	Kinesiofobia related to TMD	Questionnaire TSK-TMD. Score from 12 to 48 points	Before the F-6MMT
Secondary	Health status	Patient Health Questionnaire-4 (PHQ-4). Score from 0 to 12.	Before the F-6MMT
Secondary	Comorbidities	Central Sensitization Inventory. Score from 0 to 125 and a checklist	Before the F-6MMT