The Effect of Intentional Hard Gum Chewing on Facial Morphology: a 3DMD-based Analysis x
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in Facial Morphology Assessed by 3dMD Stereophotogrammetry
研究概览
简要总结
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.
详细描述
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.
The 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.
Three-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.
The 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.
Because 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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 (<6 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.
结局指标
主要结局
Changes in Facial Morphology Assessed by 3dMD Stereophotogrammetry
时间窗: Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks)
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.
次要结局
- Soft-Tissue Surface Topography Changes(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Change in Body Weight(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Body Height(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Participant-Reported Muscle Fatigue, Soreness, and Facial Definition Perception(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Symptom Questionnaire(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Oral Behaviors(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Patient Health Questionnaire-4 (PHQ-4)(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Jaw Functional Limitation Scale-8 (JFLS-8)(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Patient Health Questionnaire-9 (PHQ-9)(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Jaw Functional Limitation Scale-20 (JFLS-20)(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Patient Health Questionnaire-15 (PHQ-15)(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
- Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Clinical Examination(Baseline (T0), Post-Intervention (T1, 4-5 weeks), and Washout (T2, 8-9 weeks))
研究者
Flavio Uribe
Chair, Orthodontics UConn School of Dental Medicine
UConn Health