Hereditary Hemorrhagic TelangiectasiaNCT03549949
Nationwide Awareness Campaign and Call for Dental Screening for HHT in Germany
An observational study of Hereditary Hemorrhagic Telangiectasia and Dental Diseases, run by University Hospital, Essen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Hemorrhagic Telangiectasia, Dental Diseases
- How many people
- 411 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- patients having telangiectasia and nosebleeds or nosebleeds in the family
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Keywords
- pulmonary arteriovenous malformations
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Stomatognathic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (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)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Jun 2018
- Primary completion30 Sep 2019
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hereditary Hemorrhagic TelangiectasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg, University Hospital, Aachen, German HHT self-help group
- Responsible party
- Principal investigator, Urban Geisthoff, Philipps University Marburg
- Investigators
- Urban Geisthoff, Prof. Dr. med., Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549949
- Sponsor's protocol ID
- Dental Screening for HHT
- Status last verified
- Mar 2022
- First submitted
- 26 May 2018
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10751092Pierucci P, Lenato GM, Suppressa P, Lastella P, Triggiani V, Valerio R, Comelli M, Salvante D, Stella A, Resta N, Logroscino G, Resta F, Sabba 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. doi: 10.1186/1750-1172-7-33.
PubMed 22676497Kroon 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.
PubMed 29470256
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Awareness Campaign and Call for Dental Screening for HHT in Germany
- ClinicalTrials.gov ID
- NCT03549949
- Acronym / sponsor ID
- Dental Screening for HHT
- Keywords
- pulmonary arteriovenous malformations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 411 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Philipps University Marburg, University Hospital, Aachen, German HHT self-help group
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- Jul 2022 (estimated)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- patients having telangiectasia and nosebleeds or nosebleeds in the family
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 10751092Shovlin 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.
- Background: PubMed 22676497Pierucci P, Lenato GM, Suppressa P, Lastella P, Triggiani V, Valerio R, Comelli M, Salvante D, Stella A, Resta N, Logroscino G, Resta F, Sabba 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. doi: 10.1186/1750-1172-7-33.
- Background: PubMed 29470256Kroon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urban Geisthoff, Prof. Dr. med. principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Hemorrhagic Telangiectasia and Dental Diseases, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of inquiries to the German self-help group (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.