Effects of Hard Gum Chewing on Facial Soft Tissue Morphology
ConditionFace
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorUConn Health
About this trial
This pilot clinical trial will evaluate whether intentional chewing of a standardized hard chewing gum for 4 weeks produces measurable changes in facial morphology in healthy adults. Twenty participants aged 20-40 years will undergo three-dimensional facial imaging (3dMD) at baseline (T0), after the 4-week chewing intervention (T1), and following a 4-5-week washout period (T2). Changes in facial soft-tissue morphology will be assessed using three-dimensional surface analysis, including heatmaps, regional surface displacement, and morphometric measurements. Secondary outcomes include self-reported muscle fatigue, soreness, adherence, and temporomandibular disorder (TMD) symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy, non-smoking adults.
Age 20 to 40 years.
Presence of a full dentition from central incisor to first molar in all four quadrants, excluding second molars.
Stable occlusion with no ongoing orthodontic treatment or myofunctional therapy.
Disqualifiers
Age younger than 20 years or older than 40 years.
Evident facial asymmetry from a frontal view.
Signs or symptoms of temporomandibular disorders (TMD) according to the Diagnostic Criteria for TMD (DC/TMD).
Less than the normal range of condylar motion during maximum opening and closing.
Trial design
Design model
Single group
Treatments tested in this trial
Hard Gum Chewing
BehavioralParticipants will chew a standardized hard chewing gum (Jawliner®, hard hardness level) every other day for 4 weeks. Each session will consist of two 8-minute chewing blocks following a standardized protocol with controlled chewing pace, progressive force application, and alternating chewing sides. Total chewing time per session will be approximately 16 minutes.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Hard Gum Chewing InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Facial Morphology Assessed by 3dMD Stereophotogrammetry
Quantification of facial morphology changes using three-dimensional stereophotogrammetry, including regional surface distance maps (heatmaps), linear and angular measurements, and global and regional RMS deviation values.
Time frame
Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks)Secondary outcomes
1
Soft-Tissue Surface Topography Changes
Evaluation of localized hypertonia and volumetric shifts using three-dimensional heatmap analysis and regional surface displacement measurements.
Time frame
Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks)2
Change in Body Weight
Body weight will be measured in kilograms using a calibrated digital scale to monitor changes in body weight that could influence facial soft-tissue morphology.
Time frame
Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks)3
Body Height
Standing height will be measured in centimeters using a Scale. Height will be used together with body weight to characterize participants' body size and, when applicable, to calculate body mass index.
Time frame
Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks)4
Participant-Reported Muscle Fatigue, Soreness, and Facial Definition Perception
Self-reported outcomes related to muscle fatigue, soreness, chewing effort, and perceived facial definition collected through study questionnaires.
Time frame
Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
UConn Health
Lead sponsor
Charles Burstone Foundation
Collaborator
Source ClinicalTrials.gov