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NCT Number: NCT07273123

The Effect of Prolonged Sugar-Free Chewing Gum Mastication on Self-Reported Fatigue Levels and Changes of Static and Dynamic Surface Electromyography Parameters in Young Individuals With and Without Temporomandibular Joint Disorders.

This case-control study investigates fatigue induced by prolonged gum mastication in individuals with temporomandibular disorders (TMD). The study addresses two primary questions:

How does self-reported fatigue, measured with a visual analogue scale (VAS), change during sustained chewing? How do static and dynamic surface electromyographic (sEMG) parameters evolve over the same period? Participants with TMD will be compared with healthy controls to determine group differences in perceived fatigue and EMG responses.

All participants will undergo baseline EMG assessment, then chew sugar-free gum continuously for 3 minutes, alternating sides without rest. After each 3-minute interval, static and dynamic EMG recordings will be obtained and participants will rate their fatigue on the VAS. This cycle may be repeated up to six times (maximum 18 minutes). Participants are free to stop chewing at any time if fatigue becomes intolerable.

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Key information

Conditions

Temporomandibular Joint Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(both groups):

  • Age 19-35 years
  • Chewing-gum users, even occasional
  • Good general health
  • Good oral health

Inclusion criteria

(Healthy controls):

  • no diagnosed temporomandibular joint disorders

Inclusion criteria

(study group)

  • diagnosed temporomandibular joint disorders

Exclusion criteria

(both groups):

  • Non chewing gum users
  • History of neurological disorders
  • History of musculoskeletal diseases
  • History of facial or cervical injuries
  • Presence of cervical pain
  • Two or more missing teeth
  • Current treatment with fixed or removable orthodontic appliances
  • Active periodontal disease
  • Presence of cavitated carious lesions

Treatment and study plan

Mastication of sugar-free chewing gum

Other

The chewing task will last for a maximum of 18 minutes.

Primary outcomes

  1. Self-reported (subjective) fatigue after prolonged sugar-free chewing gum mastication

    Time frame: The whole session has a maximum duration of 18 minutes, assessments are done every 3 minutes

Secondary outcomes

  1. Changes of static and dynamic surface electromyography (sEMG) parameters after prolonged mastication of sugar-free chewing gum

    Time frame: The whole session has a maximum duration of 18 minutes, assessments are done every 3 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Aesha Allam, DDS

CONTACT

[email protected]

+39 3276218958

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

Effect of Sugar-Free Chewing Gum Mastication on Fatigue of the Masticatory Muscles in Young Adults With and Without Temporomandibular Joint Disorders

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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