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Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04217538
Recruitment Status : Completed
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

Condition or disease Intervention/treatment
Epidermolysis Bullosa Other: clinical exam

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : January 4, 2017
Actual Primary Completion Date : December 11, 2019
Actual Study Completion Date : December 11, 2019

Group/Cohort Intervention/treatment
EBH Other: clinical exam
clinical oral examination

Primary Outcome Measures :
  1. Dental structural abnormalities and/or caries [ Time Frame: 1 day ]
    number of defect /dental caries dor each toth

Secondary Outcome Measures :
  1. gingival biotype [ Time Frame: 1 day ]
    clinical observation of gingiva (thin or thick)

  2. gingival status [ Time Frame: 1 day ]
    observation and classification of the gingiva (healthy, inflammed or hyperplastic)

  3. plaque and gingival index [ Time Frame: 1 day ]
    registration of plaque and gingival index according to the Loë and Silness method

  4. oral lesion [ Time Frame: 1 day ]
    number and localisation of the blister/scars/flanges scars on a sketch of a mouth

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Months to 78 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients with EBH are recruted from the 2 MRDRC of the disease in France and the one of Belgium, the dental visit was/is organized for each visit/follow up of the patient in the center (annual or bianual visit)

Inclusion Criteria:

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

Exclusion Criteria:


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 identifier (NCT number): NCT04217538

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Nice Hospital
Nice, France, 06000
Toulouse University
Toucy, France, 33000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT04217538    
Other Study ID Numbers: 19-ODONTO-01
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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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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Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous