跳至主要内容
临床试验/NCT03580785
NCT03580785招募中不适用

Primary Failure of Eruption (PFE) : Highlighting of Clinical, Radiological and Genetic Diagnostic Criteria: Consequences on the Therapeutic Management

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年10月22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
50
试验地点
1
主要终点
Nutritional deficiencies

研究概览

简要总结

The primary purpose of the study is to identify clinical, radiological and genetic diagnostic criteria for Primary Failure of Eruption (PFE).

The secondary purposes are to highlight the genotype-phenotype correlations in the PTHR1 and non-PTHR1 forms and analyze the therapeutic failures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •people over 6 years old
  • •people with Primary Failure Eruption

排除标准

  • •children under 6 years old
  • •endocrine pathology that may interfere with dental eruption
  • •chemotherapy / radiotherapy
  • •bisphosphonate treatment

结局指标

主要结局

Nutritional deficiencies

时间窗: at inclusion (day 1)

nutritional deficiencies assessed by a questionnaire

Chewing

时间窗: at inclusion (day 1)

Assessment of chewing by Plana's Functional Masticatory Angles (PFMA)

Nasal breathing

时间窗: at inclusion (day 1)

Assessment of nasal breathing by the Rosenthal's test

Number of teeth

时间窗: at inclusion (day 1)

number of teeth

Recording of dental caries

时间窗: at inclusion (day 1)

recording of dental caries by Decayed Missing Filled Teeth index (DMFT index)

Recording the location of dental caries

时间窗: at inclusion (day 1)

the number of teeth affected using the international classification index

Drugs intra uterine exposure

时间窗: at inclusion (day 1)

drugs during pregnancy

Periodontium

时间窗: at inclusion (day 1)

assessment of the periodontium by Maynard and Wilson classification

Oral hygiene

时间窗: at inclusion (day 1)

assesment of oral hygiene by plaque index (Löe and Silness, 1963)

Profile (shape)

时间窗: at inclusion (day 1)

assessment of the profile (shape)

Smile

时间窗: at inclusion (day 1)

morphology of the smile

Gingival inflammation

时间窗: at inclusion (day 1)

assesment of gingival inflammation by gingival index (Löe and Silness, 1963)

Treatment needs

时间窗: at inclusion (day 1)

assessment of treatment needs using Community Periodontal Index of treatment Needs (CPITN)

Face shape

时间窗: at inclusion (day 1)

assesment of the face shape : round, square, oval

Symmetry of the face

时间窗: at inclusion (day 1)

symmetry of the face (yes/no)

Vertical dimension

时间窗: at inclusion (day 1)

assessment of the vertical dimension: anterior infraclusion or overbite (in %)

Transversal dimension

时间窗: at inclusion (day 1)

assessment of the transversal dimension: posterior transversal dimension (in mm)

Sagittal dimension

时间窗: at inclusion (day 1)

Assessment of the sagittal dimension by Angle's classification

Swallowing

时间窗: at inclusion (day 1)

Assessment of swallowing by lingual interposition

次要结局

  • Type of treatment performed(at inclusion (day 1))
  • Mutations causing PFE(at inclusion (day 1))

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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