Nationwide Awareness Campaign and Call for Dental Screeni... | NCT03549949

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

NCT03549949

Sponsor

University Hospital, Essen

Status

Unknown status

Last Update Posted

Apr 1, 2022Actual

Enrollment

411Actual

Phase

Not provided

Conditions

Hereditary Hemorrhagic Telangiectasia
Dental Diseases

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Jul 2022Estimated

First Submitted Date

May 26, 2018

First Submission Date that Met QC Criteria

May 26, 2018

First Posted Date

Jun 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2022

Last Update Posted Date

Apr 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Urban Geisthoff, Prof. Dr. med., Philipps University MarburgPrincipal Investigator

Lead Sponsor

University Hospital, EssenOTHER

Collaborators

Name	Class
Philipps University Marburg	OTHER
University Hospital, Aachen	OTHER
German HHT self-help group	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

411Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients having telangiectasia and nosebleeds or nosebleeds in the family

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urban Geisthoff, Prof. Dr. med.	Philipps University Marburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Marburg		Marburg		35043	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10751092	Background	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. doi: 10.1002/(sici)1096-8628(20000306)91:13.0.co;2-p.
22676497	Background

ID	Term
D013683	Telangiectasia, Hereditary Hemorrhagic
D009057	Stomatognathic Diseases

ID	Term
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013684	Telangiectasis