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

Dental Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03549949
• Other study ID #: Dental Screening for HHT
• Status: Active, not recruiting
• Start date: June 1, 2018
• Est. completion date: July 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 411
• Est. completion date: July 2022
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients having telangiectasia and nosebleeds or nosebleeds in the family

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Dental Diseases
• Hereditary Hemorrhagic Telangiectasia
• Stomatognathic Diseases
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Locations

Country	Name	City	State
Germany	University Hospital Marburg	Marburg

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Essen	German HHT self-help group, Philipps University Marburg Medical Center, University Hospital, Aachen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Kroon S, Snijder RJ, Faughnan ME, Mager HJ. Systematic screening in hereditary hemorrhagic telangiectasia: a review. Curr Opin Pulm Med. 2018 May;24(3):260-268. doi: 10.1097/MCP.0000000000000472. Review. — View Citation

Pierucci P, Lenato GM, Suppressa P, Lastella P, Triggiani V, Valerio R, Comelli M, Salvante D, Stella A, Resta N, Logroscino G, Resta F, Sabbà C. A long diagnostic delay in patients with Hereditary Haemorrhagic Telangiectasia: a questionnaire-based retrospective study. Orphanet J Rare Dis. 2012 Jun 7;7:33. — View Citation

Shovlin CL, Guttmacher AE, Buscarini E, Faughnan ME, Hyland RH, Westermann CJ, Kjeldsen AD, Plauchu H. Diagnostic criteria for hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber syndrome). Am J Med Genet. 2000 Mar 6;91(1):66-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of inquiries to the German self-help group	Number of inquiries to the German self-help group before and after publication of the articles.	1 year
Secondary	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)	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.	1 year