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

Primary Purpose

Primary Failure of Eruption

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
genetic analysis
panoramic radiography
teleradiography
intraoral X-rays
CT scan of maxillary and mandible
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Failure of Eruption

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique dentaireRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mutations causing PFE
Type of treatment performed
(orthodontics, surgery, prothesis)

Full Information

First Posted
April 5, 2018
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03580785
Brief Title
Primary Failure of Eruption (PFE) : Highlighting of Clinical, Radiological and Genetic Diagnostic Criteria: Consequences on the Therapeutic Management
Official Title
Primary Failure of Eruption (PFE) : Highlighting of Clinical, Radiological and Genetic Diagnostic Criteria: Consequences on the Therapeutic Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
October 12, 2023 (Anticipated)
Study Completion Date
October 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Failure of Eruption

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
genetic analysis
Intervention Description
saliva is collected for DNA extraction
Intervention Type
Radiation
Intervention Name(s)
panoramic radiography
Intervention Description
panoramic radiography
Intervention Type
Radiation
Intervention Name(s)
teleradiography
Intervention Description
teleradiography
Intervention Type
Radiation
Intervention Name(s)
intraoral X-rays
Intervention Description
intraoral X-rays
Intervention Type
Radiation
Intervention Name(s)
CT scan of maxillary and mandible
Intervention Description
CT scan of maxillary and mandible
Primary Outcome Measure Information:
Title
Number of teeth
Description
number of teeth
Time Frame
at inclusion (day 1)
Title
Recording of dental caries
Description
recording of dental caries by Decayed Missing Filled Teeth index (DMFT index)
Time Frame
at inclusion (day 1)
Title
Recording the location of dental caries
Description
the number of teeth affected using the international classification index
Time Frame
at inclusion (day 1)
Title
Drugs intra uterine exposure
Description
drugs during pregnancy
Time Frame
at inclusion (day 1)
Title
Nutritional deficiencies
Description
nutritional deficiencies assessed by a questionnaire
Time Frame
at inclusion (day 1)
Title
Periodontium
Description
assessment of the periodontium by Maynard and Wilson classification
Time Frame
at inclusion (day 1)
Title
Oral hygiene
Description
assesment of oral hygiene by plaque index (Löe and Silness, 1963)
Time Frame
at inclusion (day 1)
Title
Gingival inflammation
Description
assesment of gingival inflammation by gingival index (Löe and Silness, 1963)
Time Frame
at inclusion (day 1)
Title
Treatment needs
Description
assessment of treatment needs using Community Periodontal Index of treatment Needs (CPITN)
Time Frame
at inclusion (day 1)
Title
Face shape
Description
assesment of the face shape : round, square, oval
Time Frame
at inclusion (day 1)
Title
Symmetry of the face
Description
symmetry of the face (yes/no)
Time Frame
at inclusion (day 1)
Title
Profile (shape)
Description
assessment of the profile (shape)
Time Frame
at inclusion (day 1)
Title
Smile
Description
morphology of the smile
Time Frame
at inclusion (day 1)
Title
Vertical dimension
Description
assessment of the vertical dimension: anterior infraclusion or overbite (in %)
Time Frame
at inclusion (day 1)
Title
Transversal dimension
Description
assessment of the transversal dimension: posterior transversal dimension (in mm)
Time Frame
at inclusion (day 1)
Title
Sagittal dimension
Description
Assessment of the sagittal dimension by Angle's classification
Time Frame
at inclusion (day 1)
Title
Chewing
Description
Assessment of chewing by Plana's Functional Masticatory Angles (PFMA)
Time Frame
at inclusion (day 1)
Title
Nasal breathing
Description
Assessment of nasal breathing by the Rosenthal's test
Time Frame
at inclusion (day 1)
Title
Swallowing
Description
Assessment of swallowing by lingual interposition
Time Frame
at inclusion (day 1)
Secondary Outcome Measure Information:
Title
Mutations causing PFE
Time Frame
at inclusion (day 1)
Title
Type of treatment performed
Description
(orthodontics, surgery, prothesis)
Time Frame
at inclusion (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion STRUB, Doctor
Phone
388116956
Ext
0033
Email
marion.strub@chru-strasbourg.fr
Facility Information:
Facility Name
Clinique dentaire
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Strub

12. IPD Sharing Statement

Learn more about this trial

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

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