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.

Study Overview

• Status: Recruiting
• Conditions: Primary Failure of Eruption
• Intervention / Treatment: Genetic: genetic analysis; Radiation: panoramic radiography; Radiation: teleradiography; Radiation: intraoral X-rays; Radiation: CT scan of maxillary and mandible

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion STRUB, Doctor; Phone Number: 0033 388116956; Email: marion.strub@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • Clinique dentaire
    • Contact: Marion Strub

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mutations causing PFE		at inclusion (day 1)
Type of treatment performed	(orthodontics, surgery, prothesis)	at inclusion (day 1)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Estimated): October 12, 2023
• Study Completion (Estimated): October 12, 2023

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Exanthema
• Other Study ID Numbers: 6641

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No