[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07726511":3,"trial-entities:NCT07726511":159,"trial-summary:NCT07726511":163},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":44,"secondary_outcomes":49,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":15,"eligibility_criteria":92,"std_ages":114,"locations":116,"central_contacts":129,"overall_officials":138,"references":144,"see_also_links":158},"NCT07726511","26-191-1","Effects of Hard Gum Chewing on Facial Soft Tissue Morphology","The Effect of Intentional Hard Gum Chewing on Facial Morphology: a 3DMD-based Analysis x","RECRUITING","2028-06-30","2026-07","2026-07-24","2026-06-03","UConn Health","OTHER",false,"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.","Facial morphology is influenced by multiple functional factors, including masticatory muscle activity. Although hard gum chewing has been promoted as a method to improve facial definition and jawline appearance, there is limited scientific evidence demonstrating whether intentional chewing can produce measurable changes in facial soft tissues.\n\nThe purpose of this prospective pilot clinical trial is to evaluate the effect of intentional hard gum chewing on facial morphology using three-dimensional stereophotogrammetry (3dMD). Twenty healthy adults aged 20-40 years will be enrolled. Participants will complete a standardized hard-gum chewing protocol every other day for 4 weeks. Each chewing session will last approximately 16 minutes and will follow a predefined protocol designed to provide a consistent masticatory stimulus.\n\nThree-dimensional facial images will be obtained at baseline (T0), immediately after the intervention period (T1), and after a 4-5-week washout period (T2). Facial changes will be assessed through surface registration techniques, heatmap analysis, regional displacement measurements, and linear and angular soft-tissue measurements. Participants will also complete questionnaires regarding muscle fatigue, soreness, oral behaviors, and temporomandibular symptoms.\n\nThe primary objective is to determine whether intentional hard gum chewing produces measurable changes in facial morphology. Secondary objectives include evaluating participant-reported outcomes and monitoring for adverse events or symptoms suggestive of temporomandibular disorders.\n\nBecause this is a pilot study, the results will be used to estimate effect sizes and feasibility for future larger clinical trials investigating the relationship between masticatory activity and facial soft-tissue adaptation.",[19],"Face",[21,22,23,24,25,26,27,28,29,30],"Hard Gum Chewing","Facial Morphology","3dMD","Stereophotogrammetry","Facial Soft Tissue","Heatmap Analysis","Chewing Gum","Masticatory Muscles","Three-Dimensional Imaging","Surface Distance Mapping","INTERVENTIONAL","BASIC_SCIENCE",[34],"NA",{"count":36,"type":37},20,"ESTIMATED",[39],{"type":40,"name":21,"description":41,"armGroupLabels":42},"BEHAVIORAL","Participants 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.",[43],"Hard Gum Chewing Intervention",[45],{"measure":46,"description":47,"timeFrame":48},"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.","Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks)",[50,53,56,59,62,65,68,71,74,77,80,83,86],{"measure":51,"description":52,"timeFrame":48},"Soft-Tissue Surface Topography Changes","Evaluation of localized hypertonia and volumetric shifts using three-dimensional heatmap analysis and regional surface displacement measurements.",{"measure":54,"description":55,"timeFrame":48},"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.",{"measure":57,"description":58,"timeFrame":48},"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.",{"measure":60,"description":61,"timeFrame":48},"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.",{"measure":63,"description":64,"timeFrame":48},"Diagnostic Criteria for Temporomandibular Disorders (DC\u002FTMD) Symptom Questionnaire","Assessment of temporomandibular disorder symptoms using the Diagnostic Criteria for Temporomandibular Disorders (DC\u002FTMD) Axis I Symptom Questionnaire. This questionnaire is part of the standardized DC\u002FTMD diagnostic protocol and evaluates jaw pain, headache attributed to TMD, joint noises, jaw locking, and functional symptoms. Responses are recorded as presence or absence of symptoms and do not generate a total score. Presence\u002Fabsence of symptoms (Yes\u002FNo). This questionnaire does not generate a total score.",{"measure":66,"description":67,"timeFrame":48},"Oral Behaviors","Assessment of oral parafunctional behaviors using the Oral Behaviors Checklist (OBC), one of the DC\u002FTMD Axis II instruments. The questionnaire consists of 21 items assessing awake and sleep-related oral behaviors. A total score ranging from 0 to 84 will be calculated, with higher scores indicating more frequent oral parafunctional behaviors.",{"measure":69,"description":70,"timeFrame":48},"Patient Health Questionnaire-4 (PHQ-4)","Assessment of psychological distress using the Patient Health Questionnaire-4 (PHQ-4), included as part of the DC\u002FTMD Axis II psychosocial assessment. Total scores range from 0 to 12, with higher scores indicating greater psychological distress.",{"measure":72,"description":73,"timeFrame":48},"Jaw Functional Limitation Scale-8 (JFLS-8)","Assessment of jaw functional limitation using the Jaw Functional Limitation Scale-8 (JFLS-8), a DC\u002FTMD Axis II instrument. The questionnaire evaluates limitations in mastication, jaw mobility, and verbal and emotional expression. Scores range from 0 to 10, with higher scores indicating greater functional limitation.",{"measure":75,"description":76,"timeFrame":48},"Patient Health Questionnaire-9 (PHQ-9)","Assessment of depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9), administered as part of the DC\u002FTMD Axis II psychosocial evaluation. Total scores range from 0 to 27, with higher scores indicating greater depression severity.",{"measure":78,"description":79,"timeFrame":48},"Jaw Functional Limitation Scale-20 (JFLS-20)","Assessment of jaw functional limitation using the Jaw Functional Limitation Scale-20 (JFLS-20), a DC\u002FTMD Axis II instrument. Scores range from 0 to 10, with higher scores indicating greater functional limitation.",{"measure":81,"description":82,"timeFrame":48},"Generalized Anxiety Disorder-7 (GAD-7)","Assessment of anxiety symptoms using the Generalized Anxiety Disorder-7 (GAD-7), administered as part of the DC\u002FTMD Axis II psychosocial evaluation. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.",{"measure":84,"description":85,"timeFrame":48},"Patient Health Questionnaire-15 (PHQ-15)","Assessment of somatic symptom burden using the Patient Health Questionnaire-15 (PHQ-15), administered as part of the DC\u002FTMD Axis II psychosocial evaluation. Total scores range from 0 to 30, with higher scores indicating greater somatic symptom severity.",{"measure":87,"description":88,"timeFrame":48},"Diagnostic Criteria for Temporomandibular Disorders (DC\u002FTMD) Clinical Examination","Clinical examination performed according to the Diagnostic Criteria for Temporomandibular Disorders (DC\u002FTMD) Axis I Examination Protocol, including mandibular range of motion (mm), pain on palpation of the temporomandibular joints and masticatory muscles, pain during mandibular movements, joint sounds, and diagnostic clinical findings. Continuous variables will be reported in millimeters, and categorical findings will be reported as present or absent.","ALL","20 Years","40 Years",{"inclusion":93,"exclusion":100,"raw_text":113},[94,95,96,97,98,99],"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.","Ability and willingness to comply with the prescribed hard-gum chewing regimen for 4 weeks and attend all study visits.","Ability to provide written informed consent.",[101,102,103,104,105,106,107,108,109,110,111,112],"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\u002FTMD).","Less than the normal range of condylar motion during maximum opening and closing.","Parafunctional habits such as bruxism with pain, clenching, or habitual gum chewing for more than 1 hour per day.","History of major craniofacial trauma, orthognathic surgery, or congenital craniofacial anomalies.","Ongoing orthodontic treatment or recent removal of fixed appliances (\\\u003C6 months).","Significant malocclusion or missing teeth in the anterior or premolar-first molar region that may affect mastication.","Systemic diseases or medications affecting muscle or bone metabolism.","Previous use of botulinum toxin (Botox) within the last 6 months or anticipated use during the study period.","Pregnancy or lactation.","Allergy or intolerance to the chewing gum ingredients.","Inclusion Criteria:\n\n* Healthy, non-smoking adults.\n* Age 20 to 40 years.\n* Presence of a full dentition from central incisor to first molar in all four quadrants, excluding second molars.\n* Stable occlusion with no ongoing orthodontic treatment or myofunctional therapy.\n* Ability and willingness to comply with the prescribed hard-gum chewing regimen for 4 weeks and attend all study visits.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Age younger than 20 years or older than 40 years.\n* Evident facial asymmetry from a frontal view.\n* Signs or symptoms of temporomandibular disorders (TMD) according to the Diagnostic Criteria for TMD (DC\u002FTMD).\n* Less than the normal range of condylar motion during maximum opening and closing.\n* Parafunctional habits such as bruxism with pain, clenching, or habitual gum chewing for more than 1 hour per day.\n* History of major craniofacial trauma, orthognathic surgery, or congenital craniofacial anomalies.\n* Ongoing orthodontic treatment or recent removal of fixed appliances (\\\u003C6 months).\n* Significant malocclusion or missing teeth in the anterior or premolar-first molar region that may affect mastication.\n* Systemic diseases or medications affecting muscle or bone metabolism.\n* Previous use of botulinum toxin (Botox) within the last 6 months or anticipated use during the study period.\n* Pregnancy or lactation.\n* Allergy or intolerance to the chewing gum ingredients.",[115],"ADULT",[117],{"facility":13,"status":8,"city":118,"state":119,"zip":120,"country":121,"contacts":122,"geoPoint":126},"Farmington","Connecticut","06030","United States",[123],{"name":124,"role":125},"Flavio Uribe","CONTACT",{"lat":127,"lon":128},41.71982,-72.83204,[130,134],{"name":131,"role":125,"phone":132,"email":133},"Flavio Uribe (Chair, Depto Orthodontics; UConn School of dental medic","860-679-3170","furibe@uchc.edu",{"name":135,"role":125,"phone":136,"email":137},"Georgiana Defilio","(860) 679-2550","GEDEFILIO@uchc.edu",[139,142],{"name":124,"affiliation":140,"role":141},"UConn School of dental medicine","PRINCIPAL_INVESTIGATOR",{"name":143,"affiliation":140,"role":141},"Thais Fernandes Poleti, PhD",[145,149,152,155],{"pmid":146,"type":147,"citation":148},"8133387","RESULT","Tzakis MG, Kiliaridis S, Carlsson GE. Effect of a fatigue test and chewing training on masticatory muscles. J Oral Rehabil. 1994 Jan;21(1):33-45. doi: 10.1111\u002Fj.1365-2842.1994.tb01122.x.",{"pmid":150,"type":147,"citation":151},"2609943","Tzakis MG, Kiliaridis S, Carlsson GE. Effect of chewing training on masticatory efficiency. Acta Odontol Scand. 1989 Dec;47(6):355-60. doi: 10.3109\u002F00016358909004803.",{"pmid":153,"type":147,"citation":154},"7709901","Kiliaridis S, Tzakis MG, Carlsson GE. Effects of fatigue and chewing training on maximal bite force and endurance. Am J Orthod Dentofacial Orthop. 1995 Apr;107(4):372-8. doi: 10.1016\u002Fs0889-5406(95)70089-7.",{"pmid":156,"type":147,"citation":157},"29744215","Shirai M, Kawai N, Hichijo N, Watanabe M, Mori H, Mitsui SN, Yasue A, Tanaka E. Effects of gum chewing exercise on maximum bite force according to facial morphology. Clin Exp Dent Res. 2018 Feb 22;4(2):48-51. doi: 10.1002\u002Fcre2.102. eCollection 2018 Apr.",[],{"nct_id":4,"conditions":160,"biomarkers":162},[161],"Facial Soft Tissue Morphology",[],{"nct_id":4,"found":164,"summary":165,"prompt_version":175},true,{"design":166,"status":167,"heading":168,"summary":169,"follow_up":170,"word_count":171,"commitments":172,"compensation":173,"drugs_mentioned":174},"This is an interventional pilot study involving 20 healthy adults. It is not specified if it's randomized or blinded.","completed","Hard Gum Chewing and Facial Shape Study","This study is looking at whether chewing a special hard gum, called Jawliner®, can change the shape of your face. Researchers want to see if chewing this gum every other day for four weeks makes a measurable difference in healthy adults. They will use 3D pictures of your face to see these changes. To join, you need to be a healthy adult between 20 and 40 years old, a non-smoker, and have most of your natural teeth. The study is currently unclear on its recruitment status. The main goal is to see how your facial shape changes after chewing the gum, and then again after a break.","Your facial changes will be measured at baseline, after 4-5 weeks, and again after 8-9 weeks.",107,"You would chew Jawliner® hard gum every other day for 4 weeks, with each session lasting about 16 minutes. You will also have three 3D facial imaging appointments over about 8-9 weeks.","Not stated in the trial record.",[],"v2"]