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.

April 27, 2026 updated by: Aesha Allam, University of Milan

Effect of Sugar-Free Chewing Gum Mastication on Fatigue of the Masticatory Muscles in Young Adults 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milan
      • Milan, Milan, Italy, 20142
        • Recruiting
        • University of Milan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of volunteer participants recruited from the undergraduate dentistry program and postgraduate specialty training programs at the University of Milan.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group (subjects with TMD)
This group contains subjects with temporomandibular disorders
Other: Mastication of sugar-free chewing gum
The chewing task will last for a maximum of 18 minutes.
Control group (TMD-free subjects)
This group contains healthy subjects without temporomandibular disorders
Other: Mastication of sugar-free chewing gum
The chewing task will last for a maximum of 18 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The whole session has a maximum duration of 18 minutes, assessments are done every 3 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
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
The whole session has a maximum duration of 18 minutes, assessments are done every 3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95 /25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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