Temporomandibular Joint DisorderNCT07273123
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.
An observational study of Temporomandibular Joint Disorder, run by University of Milan at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorder
- What is being tested?
- Mastication of sugar-free chewing gum
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to 30 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Age 19-35 years
- Chewing-gum users, even occasional
- Good general health
- Good oral health
- no diagnosed temporomandibular joint disorders
- diagnosed temporomandibular joint disorders
Who cannot join
- 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
Show all 9Show fewer
- Current treatment with fixed or removable orthodontic appliances
- Active periodontal disease
- Presence of cavitated carious lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Temporomandibular Joint Disorder
- Being tested
- Mastication of sugar-free chewing gum
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastication of sugar-free chewing gumOther
The chewing task will last for a maximum of 18 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Case group (subjects with TMD) | This group contains subjects with temporomandibular disorders Receives: Other: Mastication of sugar-free chewing gum | |
| Control group (TMD-free subjects) | This group contains healthy subjects without temporomandibular disorders Receives: Other: Mastication of sugar-free chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported (subjective) fatigue after prolonged sugar-free chewing gum mastication
Measured: 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
Measured: The whole session has a maximum duration of 18 minutes, assessments are done every 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Oct 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aesha Allam, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273123
- Sponsor's protocol ID
- 95 /25
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sugar-Free Chewing Gum Mastication on Fatigue of the Masticatory Muscles in Young Adults With and Without Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT07273123
- Acronym / sponsor ID
- 95 /25
- Conditions
- Temporomandibular Joint Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group (subjects with TMD) | – | Other: Mastication of sugar-free chewing gumThis group contains subjects with temporomandibular disorders |
| Control group (TMD-free subjects) | – | Other: Mastication of sugar-free chewing gumThis group contains healthy subjects without temporomandibular disorders |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Age 19-35 years
- Chewing-gum users, even occasional
- Good general health
- Good oral health
- no diagnosed temporomandibular joint disorders
Key exclusion criteria (9 listed)
- Non chewing gum users
- History of neurological disorders
- History of musculoskeletal diseases
- History of facial or cervical injuries
- Presence of cervical pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mastication of sugar-free chewing gumThe chewing task will last for a maximum of 18 minutes. | Other | Case group (subjects with TMD), Control group (TMD-free subjects) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorder, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.