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临床试验/NCT04231383
NCT04231383Unknown不适用

Evaluation of the Relationship Between Dental Caries-related Pain and Inflammation and Growth Parameters in Preschool Children

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Growth parameters

研究概览

简要总结

Untreated dental caries are very common in preschool children. Pain and inflammation due to dental caries have been reported to affect eating and sleeping disorders, affecting growth and development. The aim of this study was to compare the changes in serum IGF-1 and IGFBP-3 levels, height and weight gain before and after treatment in patients with dental caries-related inflammation and pain in preschool children and to compare these children with children without dental caries. Thirty children aged between 3-6 years with dental caries with pulp were identified using ICDAS II and dmft index as the study group.30 children dental caries including pulp, will be included using the same indices as the control group. In the study group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined before and at the 6th month after treatment. In the control group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined at the 6th month following the first dental examination. IGF-1, IGFBP-3 and anthropometric measurements will be compared between first dental examination and 6th month values in the study and control groups, and between first dental examination and 6th month time points between the groups.

详细描述

In addition to growth parameters, the Children's Sleeping Habits Questionnaire and the Early Childhood Oral Health Impact Scale will be compared before the 6th month of dental treatment and compared

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For study group
  • (3-6 years) preschool children
  • Children whose dental treatments are indicated under general anesthesia
  • Children with primary dentition
  • Children with early childhood caries (dmft index d≥ 3)
  • Children with symptoms of pulpitis or periapical infection in at least one tooth
  • Children with dental problems at least in the last 6 months
  • Volunteering to participate in the study. For the control group,
  • 1- (3-6 years) preschool children 2-Children with primary dentition 3- Children without pulpitis symptoms or periapical infection during dental examination 4-Volunteering to participate in the study.

排除标准

  • Children who do not show adequate compliance during blood sampling
  • Consent form is not signed
  • Children with chronic and systemic diseases that may affect growth and development
  • Children using anti-inflammatory
  • Patients with physical and mental disabilities
  • Patients using corticosteroids in the last 6 months
  • If a child is diagnosed with any of the these diseases during the study

结局指标

主要结局

Growth parameters

时间窗: 6 months after dental treatment

In the study group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined before and at the 6th month after treatment. In the control group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined at the 6th month following the first dental examination. IGF-1, IGFBP-3 and anthropometric measurements will be compared between first dental examination and 6th month values in the study and control groups, and between first dental examination and 6th month time points between the groups.

次要结局

  • Children's Sleep Habits Questionnaire(6 months after dental treatment)
  • Early Childhood Oral Health Impact Scale(6 months after dental treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Basak Gunay

research asistant

Bezmialem Vakif University

研究点 (1)

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