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临床试验/NCT05812690
NCT05812690已完成不适用

An International Study of Molar Incisor Hypomineralisation and Its Association With Dental Anomalies

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 1,279 人开始时间: 2022年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,279
试验地点
1
主要终点
Prevalence of a dental anomaly in children with and without MIH

研究概览

简要总结

Background/study aim:

Molar incisor hypomineralisation (MIH) is a common disorder of tooth development. Affected teeth have weak enamel and adult molars often require extensive treatment or even extraction. A preliminary study, carried out in Sheffield Dental Hospital, discovered that 12% of MIH children also had congenitally missing adult teeth, presenting further challenges to treatment-planning. This novel finding stimulated discussion between international MIH experts; whilst some clinicians had observed this association, others had not. Therefore the primary aim of this international study is to determine the association between MIH and missing teeth in different populations. This has important clinical and biological relevance in understanding the presentation and management of MIH.

Participants/research sites:

This study will include 584 children with MIH and a comparison group of 584 children without MIH. Young dental patients, aged 7-16 years, who attend for a check-up or treatment at one of the 15 participating countries will be invited to take part. The UK sites are Sheffield, Newcastle and University College London Dental Hospitals and all children will be seen by specialists/consultants in paediatric dentistry to confirm their diagnosis of MIH. The main inclusion criteria is that children have a dental xray as part of their routine care.

Data collection:

Following a routine dental check-up we will grade the severity of the participants' MIH (if present) and record any other dental anomalies (e.g. abnormal tooth number, position or shape). We will also check the dental xray for other anomalies that cannot be seen from the clinical exam. We will analyse the prevalence of MIH and association with other dental anomalies to see if there are difference according to sex or ethnicity and compare our findings with the non-MIH group. We anticipate the study will take 18 months.

详细描述

The primary objective is to compare the overall prevalence of congenitally missing teeth/hypodontia (excluding wisdom teeth) in children (7-16 years old) with and without MIH.

Secondary research questions/objectives

The secondary research objectives are to:

  1. Compare the prevalence of developmentally missing teeth (hypodontia) in MIH children based on region, ethnicity and gender
  2. Determine the clinical pattern (including symmetry), severity and treatment need of MIH in children (aged 7-16years) referred to specialist paediatric dentistry services across the world, according to gender and ethnic group/region
  3. Compare the prevalence of other co-existing developmental dental anomalies between the two groups
  4. Compare the prevalence of developing third permanent molars between the two groups

What is the scientific justification for the research?

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
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Prevalence of a dental anomaly in children with and without MIH

时间窗: recruitment until July 2023

Presence of any dental anomaly (number, shape, eruption disturbance)

次要结局

  • Characteristics associated with presence of a dental anomaly in children with MIH(recruitment until July 2023)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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