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临床试验/NCT05000385
NCT05000385招募中不适用

Association of Masticatory Efficiency With the Condition of the Stomatognathic System in Children

Clinical Hospital Center Rijeka2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
96
试验地点
2
主要终点
level of masticatory efficiency in children

研究概览

简要总结

This study aims to evaluate the association of masticatory efficiency with different conditions of the stomatognathic system (transitioning from primary to secondary dentition, dental caries, malocclusion, tooth loss, prosthodontic treatment) in the paediatric population. Also, to assess the correlation between masticatory efficiency and nutritional status. The study will be conducted on children between 3 and 14 years of age. Masticatory efficiency will be evaluated by the optical scanning method. Participants will chew a standardized silicone tablet controlled by the examiner for 20 masticatory strokes. By scanning the comminuted particles, data on each particle's size will be obtained. Enhanced masticatory performance is presented by a decrease in the chewed particle areas and an increase in the number of chewed particles.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children of both genders aged 3 to 14, with:
  • full healthy dentition
  • bilateral dental caries stage 4,5 or 6 by ICDAS criteria
  • reduced number of occlusal contacts
  • signed informed consent by participant's parents
  • verbal consent of the children

排除标准

  • uncooperative behavior
  • symptoms of temporomandibular joint dysfunction
  • parafunctional habits
  • systemic disturbances that can impact mastication
  • ingestion of medicines that could interfere directly or indirectly with muscular activity
  • tooth anomalies of structure, number or form
  • periodontal disease
  • tooth mobility

结局指标

主要结局

level of masticatory efficiency in children

时间窗: 2 years

determining the masticator efficiency variable (mean area of chewed particles) with optical scanning method, data comparison between four groups

masticatory efficiency and body mass index

时间窗: 2 years

determining the correlation of the masticatory efficiency variable (mean area of chewed particles determined by the optical scanning method) with body mass index (weight and height will be combined to report BMI in kg/m\^2)

次要结局

  • occlusal contact and masticatory efficiency(2 years)
  • dental caries and masticatory efficiency(2 years)

研究者

发起方
Clinical Hospital Center Rijeka
申办方类型
Other
责任方
Principal Investigator
主要研究者

Odri Cicvarić

DMD, Principal Investigator

Clinical Hospital Center Rijeka

研究点 (2)

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