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

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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 |
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

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
Contact: Marion STRUB, Doctor | 388116956 ext 0033 | marion.strub@chru-strasbourg.fr |
France | |
Clinique dentaire | Recruiting |
Strasbourg, France, 67000 | |
Contact: Marion Strub |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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