Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa

Completed

• Conditions: Epidermolysis Bullosa
• Interventions: Other: clinical exam

• Registration Number: NCT04217538
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-04
• Status Verified: 2019-12
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-11
• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2020-01-02
• Last Update Submitted: 2020-01-02
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EBH	clinical exam	-

Primary Outcome Measures

Name	Time	Method
Dental structural abnormalities and/or caries	1 day	number of defect /dental caries dor each toth

Secondary Outcome Measures

Name	Time	Method
oral lesion	1 day	number and localisation of the blister/scars/flanges scars on a sketch of a mouth
gingival status	1 day	observation and classification of the gingiva (healthy, inflammed or hyperplastic)
gingival biotype	1 day	clinical observation of gingiva (thin or thick)
plaque and gingival index	1 day	registration of plaque and gingival index according to the Loë and Silness method

Trial Locations

Locations (2)

Toulouse University; 🇫🇷 Toucy, France

Nice Hospital; 🇫🇷 Nice, France