Skip to main content
OpenTrials
Completed

NCT Number: NCT04217538

Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epidermolysis Bullosa Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

7 month–78 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice Hospital, Nice, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Clinical exam

Other

clinical oral examination

Primary outcomes

  1. Dental structural abnormalities and/or caries

    Time frame: 1 day

    number of defect /dental caries dor each toth

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2020
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.