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NCT Number: NCT03580785

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

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.

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Key information

Conditions

Primary Failure of Eruption

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique dentaire

Strasbourg, 67000, France

Location status: Recruiting

Location contact

Marion Strub

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic analysis

Genetic

saliva is collected for DNA extraction

Panoramic Radiography

Radiation

panoramic radiography

teleradiography

Radiation

teleradiography

intraoral X-rays

Radiation

intraoral X-rays

CT scan of maxillary and mandible

Radiation

CT scan of maxillary and mandible

Primary outcomes

  1. Number of teeth

    Time frame: at inclusion (day 1)

    number of teeth

  2. Recording of dental caries

    Time frame: at inclusion (day 1)

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

  3. Recording the location of dental caries

    Time frame: at inclusion (day 1)

    the number of teeth affected using the international classification index

  4. Drugs intra uterine exposure

    Time frame: at inclusion (day 1)

    drugs during pregnancy

  5. Nutritional deficiencies

    Time frame: at inclusion (day 1)

    nutritional deficiencies assessed by a questionnaire

  6. Periodontium

    Time frame: at inclusion (day 1)

    assessment of the periodontium by Maynard and Wilson classification

  7. Oral hygiene

    Time frame: at inclusion (day 1)

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

  8. Gingival inflammation

    Time frame: at inclusion (day 1)

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

  9. Treatment needs

    Time frame: at inclusion (day 1)

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

  10. Face shape

    Time frame: at inclusion (day 1)

    assesment of the face shape : round, square, oval

  11. Symmetry of the face

    Time frame: at inclusion (day 1)

    symmetry of the face (yes/no)

  12. Profile (shape)

    Time frame: at inclusion (day 1)

    assessment of the profile (shape)

  13. Smile

    Time frame: at inclusion (day 1)

    morphology of the smile

  14. Vertical dimension

    Time frame: at inclusion (day 1)

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

  15. Transversal dimension

    Time frame: at inclusion (day 1)

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

  16. Sagittal dimension

    Time frame: at inclusion (day 1)

    Assessment of the sagittal dimension by Angle's classification

  17. Chewing

    Time frame: at inclusion (day 1)

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

  18. Nasal breathing

    Time frame: at inclusion (day 1)

    Assessment of nasal breathing by the Rosenthal's test

  19. Swallowing

    Time frame: at inclusion (day 1)

    Assessment of swallowing by lingual interposition

Secondary outcomes

  1. Mutations causing PFE

    Time frame: at inclusion (day 1)

  2. Type of treatment performed

    Time frame: at inclusion (day 1)

    (orthodontics, surgery, prothesis)

Study contacts

Contact information is provided by the study sponsor or research team.

Marion STRUB, Doctor

CONTACT

[email protected]

388116956 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2018
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.