NCT04217538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

2.9 years

First QC Date

December 31, 2019

Last Update Submit

January 2, 2020

Conditions

Epidermolysis Bullosa

Outcome Measures

Primary Outcomes (1)

  • Dental structural abnormalities and/or caries

    number of defect /dental caries dor each toth

    1 day

Secondary Outcomes (4)

  • gingival biotype

    1 day

  • gingival status

    1 day

  • plaque and gingival index

    1 day

  • oral lesion

    1 day

Study Arms (1)

EBH

Other: clinical exam

Interventions

clinical examOTHER

clinical oral examination

EBH

Eligibility Criteria

Age7 Months - 78 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nice Hospital

Nice, 06000, France

Location

Toulouse University

Toucy, 33000, France

Location

MeSH Terms

Conditions

Epidermolysis Bullosa

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vesiculobullous

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 3, 2020

Study Start

January 4, 2017

Primary Completion

December 11, 2019

Study Completion

December 11, 2019

Last Updated

January 3, 2020

Record last verified: 2019-12

Locations

FR(2)