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

NCT03580785 | Recruiting

• 1 other identifier: 6641
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Failure of Eruption

Outcome Measures

Primary Outcomes (19)

• Number of teeth

  number of teeth

  at inclusion (day 1)

• Recording of dental caries

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

  at inclusion (day 1)

• Recording the location of dental caries

  the number of teeth affected using the international classification index

  at inclusion (day 1)

• Drugs intra uterine exposure

  drugs during pregnancy

  at inclusion (day 1)

• Nutritional deficiencies

  nutritional deficiencies assessed by a questionnaire

  at inclusion (day 1)

• Periodontium

  assessment of the periodontium by Maynard and Wilson classification

  at inclusion (day 1)

• Oral hygiene

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

  at inclusion (day 1)

• Gingival inflammation

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

  at inclusion (day 1)

• Treatment needs

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

  at inclusion (day 1)

• Face shape

  assesment of the face shape : round, square, oval

  at inclusion (day 1)

• Symmetry of the face

  symmetry of the face (yes/no)

  at inclusion (day 1)

• Profile (shape)

  assessment of the profile (shape)

  at inclusion (day 1)

• Smile

  morphology of the smile

  at inclusion (day 1)

• Vertical dimension

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

  at inclusion (day 1)

• Transversal dimension

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

  at inclusion (day 1)

• Sagittal dimension

  Assessment of the sagittal dimension by Angle's classification

  at inclusion (day 1)

• Chewing

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

  at inclusion (day 1)

• Nasal breathing

  Assessment of nasal breathing by the Rosenthal's test

  at inclusion (day 1)

• Swallowing

  Assessment of swallowing by lingual interposition

  at inclusion (day 1)

Secondary Outcomes (2)

• Mutations causing PFE

  at inclusion (day 1)

• Type of treatment performed

  at inclusion (day 1)

Interventions

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

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Clinique dentaire

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Interventions

Genetic Testing; Radiography, Panoramic

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Radiography, Dental; Radiography; Diagnostic Imaging; Diagnosis, Oral; Dentistry

Central Study Contacts

Marion STRUB, Doctor

CONTACT

388116956; marion.strub@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single group

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: July 9, 2018
• Study Start: October 22, 2018
• Primary Completion: October 12, 2025
• Study Completion: October 12, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Locations

FR (1)