Primary Failure of Eruption Clinical Trial
Official title:
Primary Failure of Eruption (PFE) : Highlighting of Clinical, Radiological and Genetic Diagnostic Criteria: Consequences on the Therapeutic Management
| NCT number | NCT03580785 |
| Other study ID # | 6641 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 22, 2018 |
| Est. completion date | October 12, 2023 |
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | October 12, 2023 |
| Est. primary completion date | October 12, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique dentaire | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of teeth | number of teeth | at inclusion (day 1) | |
| Primary | Recording of dental caries | recording of dental caries by Decayed Missing Filled Teeth index (DMFT index) | at inclusion (day 1) | |
| Primary | Recording the location of dental caries | the number of teeth affected using the international classification index | at inclusion (day 1) | |
| Primary | Drugs intra uterine exposure | drugs during pregnancy | at inclusion (day 1) | |
| Primary | Nutritional deficiencies | nutritional deficiencies assessed by a questionnaire | at inclusion (day 1) | |
| Primary | Periodontium | assessment of the periodontium by Maynard and Wilson classification | at inclusion (day 1) | |
| Primary | Oral hygiene | assesment of oral hygiene by plaque index (Löe and Silness, 1963) | at inclusion (day 1) | |
| Primary | Gingival inflammation | assesment of gingival inflammation by gingival index (Löe and Silness, 1963) | at inclusion (day 1) | |
| Primary | Treatment needs | assessment of treatment needs using Community Periodontal Index of treatment Needs (CPITN) | at inclusion (day 1) | |
| Primary | Face shape | assesment of the face shape : round, square, oval | at inclusion (day 1) | |
| Primary | Symmetry of the face | symmetry of the face (yes/no) | at inclusion (day 1) | |
| Primary | Profile (shape) | assessment of the profile (shape) | at inclusion (day 1) | |
| Primary | Smile | morphology of the smile | at inclusion (day 1) | |
| Primary | Vertical dimension | assessment of the vertical dimension: anterior infraclusion or overbite (in %) | at inclusion (day 1) | |
| Primary | Transversal dimension | assessment of the transversal dimension: posterior transversal dimension (in mm) | at inclusion (day 1) | |
| Primary | Sagittal dimension | Assessment of the sagittal dimension by Angle's classification | at inclusion (day 1) | |
| Primary | Chewing | Assessment of chewing by Plana's Functional Masticatory Angles (PFMA) | at inclusion (day 1) | |
| Primary | Nasal breathing | Assessment of nasal breathing by the Rosenthal's test | at inclusion (day 1) | |
| Primary | Swallowing | Assessment of swallowing by lingual interposition | at inclusion (day 1) | |
| Secondary | Mutations causing PFE | at inclusion (day 1) | ||
| Secondary | Type of treatment performed | (orthodontics, surgery, prothesis) | at inclusion (day 1) |