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

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ClinicalTrials.gov Identifier: NCT03580785
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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.


Condition or disease Intervention/treatment Phase
Primary Failure of Eruption Genetic: genetic analysis Radiation: panoramic radiography Radiation: teleradiography Radiation: intraoral X-rays Radiation: CT scan of maxillary and mandible Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single group
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Primary Failure of Eruption (PFE) : Highlighting of Clinical, Radiological and Genetic Diagnostic Criteria: Consequences on the Therapeutic Management
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : July 12, 2021
Estimated Study Completion Date : July 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arms and Interventions
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Intervention Details:
  • Genetic: genetic analysis
    saliva is collected for DNA extraction
  • Radiation: panoramic radiography
    panoramic radiography
  • Radiation: teleradiography
    teleradiography
  • Radiation: intraoral X-rays
    intraoral X-rays
  • Radiation: CT scan of maxillary and mandible
    CT scan of maxillary and mandible

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Mutations causing PFE [ Time Frame: at inclusion (day 1) ]
  2. Type of treatment performed [ Time Frame: at inclusion (day 1) ]
    (orthodontics, surgery, prothesis)


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580785


Contacts
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Contact: Marion STRUB, Doctor 388116956 ext 0033 marion.strub@chru-strasbourg.fr

Locations
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France
Clinique dentaire Recruiting
Strasbourg, France, 67000
Contact: Marion Strub         
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03580785    
Other Study ID Numbers: 6641
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Exanthema
Skin Diseases