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Status of Dental Care Practices in Patients With Hereditary Angioedema

NCT ID: NCT05776784

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-27

Study Completion Date

2023-12-31

Brief Summary

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Hereditary angioedema (HAE) is a rare genetic disease, it can occur at any age and evolves in flare-ups. These are subcutaneous or submucosal edemas responsible for tightness and pain. All areas can be reached. In addition, all their life, patients have an unpredictable risk of death from asphyxiating angioedema (25% mortality in the absence of specific treatment).

Surgical procedures, endoscopies and dental procedures can trigger laryngeal AE. Thus, the national reference center for angioedema (CREAK) and the latest international consensus1 recommend that all these procedures be preceded by short-term prophylaxis. The reference treatment is the C1 inhibitor 2 concentrate. But to date, there is no prospective study that has demonstrated the effectiveness of this short-term prophylaxis before dental treatment. Only a retrospective study has shown that its implementation made it possible to reduce the risk of crisis by 42% after tooth extraction 3 and that the risk of crisis was greatest within 8 hours following tooth extraction.

The C1 inhibitor concentrate must be administered IVL by a nurse within 6 hours before the procedure and therefore implies, in addition to its high cost (1500 €), an organizational burden for the patient who must plan for the passage of an IDE, the availability of the product and this sometimes for a simple dental treatment.

These constraints have two consequences for dental care: patients avoid going to the dentist to the detriment of their dental health or do not take prophylaxis with the risk of a fatal attack.

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Detailed Description

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Conditions

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Angio Edema Hereditary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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dental procedure

questionnaire for patient with dental procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient with HAE with or without C1 Inhibitor deficiency
* Patient over 18 years old

Exclusion Criteria

* Patient opposed to the use of their data or refusing to answer the questionnaire
* Adult patients protected by law
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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chu grenoble alpes CREAK

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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melanie arnaud

Role: CONTACT

[email protected]
+33476767838

bruna ducotterd

Role: CONTACT

[email protected]
+33476767838

Facility Contacts

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melanie arnaud

Role: primary

[email protected]
+33476767838

Other Identifiers

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38RC22.0357

Identifier Type: -

Identifier Source: org_study_id

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