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Nationwide Awareness Campaign and Call for Dental Screening for HHT in Germany

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ClinicalTrials.gov Identifier: NCT03549949
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Philipps University Marburg Medical Center
University Hospital, Aachen
German HHT self-help group
Information provided by (Responsible Party):
Urban Geisthoff, Philipps University Marburg Medical Center

Brief Summary:
HHT is a relative rare autosomal dominant inherited disorder of the fibrovascular tissue. Diagnosis of HHT is often delayed for decades (Pierucci 2012). However, it would be desirable to achieve an early diagnosis as early screening and treatment decrease disease-associated complications and increase life expectancy (Kroon 2018). Our approach is a nationwide call and awareness campaign to dentists in Germany, as nearly all persons visit a dentist from time to time. This approach is promising to us, as most patients develop nosebleeds and multiple, typical telangiectases of the skin or mucosa. A predilection site is the oral mucosa and the face, including the lips (Shovlin 2000).

Condition or disease
Hereditary Hemorrhagic Telangiectasia Dental Diseases

Detailed Description:

The German self-help group is taking down the number of inquiries from patients and physicians per months since April 2017. In June 2018 an article about HHT is planned to be published in the journal of the German dental association and the Federal Association of Fund Dentists of Germany. This journal is distributed to all dentists in Germany and is a set book for them. Total circulation in 2017 was 77,621 (http://www.aerzteverlag.de/portfolio/fachwissen-medizindental/zm-zahnaerztliche-mitteilungen/profil/ ). The article describes the case of visceral abscesses after dental screening in a patient with HHT and pulmonary arteriovenous malformations. These could probably have been prevented if the dentist had prescribed an antibiotic prophylaxis to the patient. The article includes a call to search for telangiectases. If those are seen the dentist is recommended to ask the patient if he or relatives have nosebleeds. If both apply, the dentist is asked to inform the patient about HHT and give him the address of the national German self-help group.

After 3 and 6 months a reminder shall be published in the same journal.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nationwide Awareness Campaign and Call for Dental Screening for HHT in Germany
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019





Primary Outcome Measures :
  1. Number of inquiries to the German self-help group [ Time Frame: 1 year ]
    Number of inquiries to the German self-help group before and after publication of the articles.


Secondary Outcome Measures :
  1. Number of specific HHT diagnosis in the information system for health services (Informationssystem Versorgungsforschung) of the national German institute for medical documentation and information (DIMDI) [ Time Frame: 1 year ]
    The number of specific HHT diagnosis in the information system for health services (Informationssystem Versorgungsforschung) of the national German institute for medical documentation and information (DIMDI) will be analyzed for potential changes.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Telagiectases seen by the dentist should lead to the question if the patient or relatives have nosebleeds. If both apply, the dentist is asked to inform the patient about Hereditary Hemorrhagic Telangiectasia and give the address of the national German self-help group to the patient.
Criteria

Inclusion Criteria:

  • patients having telangiectasia and nosebleeds or nosebleeds in the family

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549949


Contacts
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Contact: Günter Dobrzewski +49 800 ext 7236044 info@morbus-osler.de
Contact: Urban Geisthoff, Prof. Dr. med. +49 6421 58 ext 66478 sekretariat.hno.mr@uk-gm.de

Sponsors and Collaborators
University Hospital, Essen
Philipps University Marburg Medical Center
University Hospital, Aachen
German HHT self-help group
Investigators
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Principal Investigator: Urban Geisthoff Philipps University Marburg Medical Center

Publications:
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Responsible Party: Urban Geisthoff, Prof. Dr. med., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03549949     History of Changes
Other Study ID Numbers: Dental Screening for HHT
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Urban Geisthoff, Philipps University Marburg Medical Center:
pulmonary arteriovenous malformations

Additional relevant MeSH terms:
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Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Stomatognathic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities