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Recruiting Not applicable

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

NCT03580785 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2018-10-22
Last updated
2025-08-03

Condition(s) studied

Primary Failure of Eruption

Investigational drug(s) / intervention(s)

genetic analysispanoramic radiographyteleradiographyintraoral X-raysCT scan of maxillary and mandible

genetic analysis: saliva is collected for DNA extraction

panoramic radiography: panoramic radiography

teleradiography: teleradiography

intraoral X-rays: intraoral X-rays

CT scan of maxillary and mandible: CT scan of maxillary and mandible

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * people over 6 years old * people with Primary Failure Eruption Exclusion criteria: * children under 6 years old * endocrine pathology that may interfere with dental eruption * rickets * chemotherapy / radiotherapy * bisphosphonate treatment

Primary outcome measure(s)

  • Number of teeth — at inclusion (day 1)
    number of teeth
  • Recording of dental caries — at inclusion (day 1)
    recording of dental caries by Decayed Missing Filled Teeth index (DMFT index)
  • Recording the location of dental caries — at inclusion (day 1)
    the number of teeth affected using the international classification index
  • Drugs intra uterine exposure — at inclusion (day 1)
    drugs during pregnancy
  • Nutritional deficiencies — at inclusion (day 1)
    nutritional deficiencies assessed by a questionnaire
  • Periodontium — at inclusion (day 1)
    assessment of the periodontium by Maynard and Wilson classification
  • Oral hygiene — at inclusion (day 1)
    assesment of oral hygiene by plaque index (Löe and Silness, 1963)
  • Gingival inflammation — at inclusion (day 1)
    assesment of gingival inflammation by gingival index (Löe and Silness, 1963)
  • Treatment needs — at inclusion (day 1)
    assessment of treatment needs using Community Periodontal Index of treatment Needs (CPITN)
  • Face shape — at inclusion (day 1)
    assesment of the face shape : round, square, oval
  • Symmetry of the face — at inclusion (day 1)
    symmetry of the face (yes/no)
  • Profile (shape) — at inclusion (day 1)
    assessment of the profile (shape)
  • Smile — at inclusion (day 1)
    morphology of the smile
  • Vertical dimension — at inclusion (day 1)
    assessment of the vertical dimension: anterior infraclusion or overbite (in %)
  • Transversal dimension — at inclusion (day 1)
    assessment of the transversal dimension: posterior transversal dimension (in mm)
  • Sagittal dimension — at inclusion (day 1)
    Assessment of the sagittal dimension by Angle's classification
  • Chewing — at inclusion (day 1)
    Assessment of chewing by Plana's Functional Masticatory Angles (PFMA)
  • Nasal breathing — at inclusion (day 1)
    Assessment of nasal breathing by the Rosenthal's test
  • Swallowing — at inclusion (day 1)
    Assessment of swallowing by lingual interposition

Trial sites (1)

FacilityCityRegionStatus
Clinique dentaire Strasbourg France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03580785 on ClinicalTrials.gov ↗ ← All trials in France