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.

NCT07273123 | Recruiting

• 1 other identifier: 95 /25
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Disorder

Outcome Measures

Primary Outcomes (1)

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

  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

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

Study Arms (2)

Case group (subjects with TMD)

This group contains subjects with temporomandibular disorders

Other: Mastication of sugar-free chewing gum

Control group (TMD-free subjects)

This group contains healthy subjects without temporomandibular disorders

Other: Mastication of sugar-free chewing gum

Interventions

Mastication of sugar-free chewing gum OTHER

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

Case group (subjects with TMD); Control group (TMD-free subjects)

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age 19-35 years
• Chewing-gum users, even occasional
• Good general health
• Good oral health
• \- no diagnosed temporomandibular joint disorders
• \- diagnosed temporomandibular joint disorders

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

University of Milan

Milan, Milan, 20142, Italy

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Aesha Allam, DDS

CONTACT

+39 3276218958; aesha.allam@unimi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Doctor, principal investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)