- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07273123
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.
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Aesha Allam, DDS
- Phone Number: +39 3276218958
- Email: aesha.allam@unimi.it
Study Locations
-
-
Milan
-
Milan, Milan, Italy, 20142
- Recruiting
- University of Milan
-
Contact:
- Aesha Allam DDS
- Phone Number: +39 3276218958
- Email: aesha.allam@unimi.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
|
The chewing task will last for a maximum of 18 minutes.
|
|
Control group (TMD-free subjects)
This group contains healthy subjects without temporomandibular disorders
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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