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.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mastication of sugar-free chewing gum.
- Who it may be relevant to
- Registry conditions: Temporomandibular Joint Disorder. Basic parameters: 19 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Sugar-Free Chewing Gum Mastication on Fatigue of the Masticatory Muscles in Young Adults With and Without Temporomandibular Joint Disorders
Overview
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.
Interventions
- Other Mastication of sugar-free chewing gum
The chewing task will last for a maximum of 18 minutes.
Primary outcome measures
- 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 outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- University of Milan — Milan
Identifiers
NCT: NCT07273123 · 95 /25