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Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa

Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa That Come for Their Annual/Biannual Check up at This Medical Rare Disease Reference Centers (MRDRC) of This Disease in France and Belgium

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04217538
Enrollment
41
Registered
2020-01-03
Start date
2017-01-04
Completion date
2019-12-11
Last updated
2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermolysis Bullosa

Brief summary

Hereditary Epidermolysis Bullosa (EBH) are rare dermatologic diseases characterized by cutaneous and mucosa fragility. Oral manifestations of few small cohort have been published. The main objective of this multicentric cohort study first in Europe was to report the oral status of these patients that were consulted in the MRDRC of this disease in Nice (France), Toulouse (France) and Louvain (Belgium). Then a correlation between the oral characteristics and the EBH type will be made, in order to facilitate the management of patient care and the prevention program that can be established to improve their oral health.

Interventions

clinical oral examination

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Months to 78 Years

Inclusion criteria

* patient with EBH * patient consent for examination and use the clinical data for publication purpose

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Dental structural abnormalities and/or caries1 daynumber of defect /dental caries dor each toth

Secondary

MeasureTime frameDescription
gingival biotype1 dayclinical observation of gingiva (thin or thick)
gingival status1 dayobservation and classification of the gingiva (healthy, inflammed or hyperplastic)
plaque and gingival index1 dayregistration of plaque and gingival index according to the Loë and Silness method
oral lesion1 daynumber and localisation of the blister/scars/flanges scars on a sketch of a mouth

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026