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.

NCT ID: NCT07273123

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Temporomandibular Joint Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Case group (subjects with TMD)

This group contains subjects with temporomandibular disorders

Mastication of sugar-free chewing gum

Intervention Type OTHER

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

Control group (TMD-free subjects)

This group contains healthy subjects without temporomandibular disorders

Mastication of sugar-free chewing gum

Intervention Type OTHER

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

Interventions

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Mastication of sugar-free chewing gum

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


\- no diagnosed temporomandibular joint disorders


\- diagnosed temporomandibular joint disorders

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Aesha Allam

DDS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Milan

Milan, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Aesha Allam, DDS

Role: CONTACT

+39 3276218958

Facility Contacts

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Aesha Allam DDS

Role: primary

+39 3276218958

Other Identifiers

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95 /25

Identifier Type: -

Identifier Source: org_study_id

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