Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT04217538
• Collaborator: (none)
• Enrollment: 41
• Locations: 2
• Actual Duration (Months): 35.2
• Patients Per Site: 20.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	Phase
Epidermolysis Bullosa	Other: clinical exam

Study Design

• 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: Jan 4, 2017
• Actual Primary Completion Date: Dec 11, 2019
• Actual Study Completion Date: Dec 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
EBH	Other: clinical exam; clinical oral examination

Outcome Measures

Primary Outcome Measures

1. Dental structural abnormalities and/or caries [1 day]

   number of defect /dental caries dor each toth

Secondary Outcome Measures

1. gingival biotype [1 day]

   clinical observation of gingiva (thin or thick)

2. gingival status [1 day]

   observation and classification of the gingiva (healthy, inflammed or hyperplastic)

3. plaque and gingival index [1 day]

   registration of plaque and gingival index according to the Loë and Silness method

4. oral lesion [1 day]

   number and localisation of the blister/scars/flanges scars on a sketch of a mouth

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Months to 78 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• patient with EBH

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nice Hospital	Nice		France	06000
2	Toulouse University	Toucy		France	33000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT04217538
• Other Study ID Numbers: 19-ODONTO-01
• First Posted: Jan 3, 2020
• Last Update Posted: Jan 3, 2020
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epidermolysis Bullosa

Study Results

No Results Posted as of Jan 3, 2020