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Gingival Bleeding and Von Willebrand Disease Typ 2 and 3

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ClinicalTrials.gov Identifier: NCT03078595
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Eickholz, Goethe University

Brief Summary:
Von Willebrand disease (VWD) is the most common inherent bleeding disorder resulting in prolonged bleeding time. Gingival bleeding is a frequently reported symptom of VWD. However, gingival bleeding is also known as a leading symptom of plaque-induced gingivitis and untreated periodontal disease. Gingival bleeding in VWD patients may be triggered by gingival inflammation and not a genuine symptom. Thus, this study evaluates whether type 2 and 3 VWD determines an increased susceptibility to gingival bleeding in response to the oral biofilm.

Condition or disease
Gingival Bleeding Von Willebrand Diseases

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Is Gingival Bleeding a Symptom of Patients With Type 2 and 3 Von Willebrand Disease? A Case-Control Study
Actual Study Start Date : July 16, 2015
Actual Primary Completion Date : April 4, 2017
Actual Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort
von Willebrand disease type 2 and 3
Examinations (haematologically and periodontally) of von Willebrand disease patients with type 2 and 3 and healthy controls to evaluate whether type 2 and 3 VWD determines an increased susceptibility to gingival bleeding in response to the oral biofilm
controls
For each case (VWD) a respective haematologically healthy control is recruited from the gingivitis and periodontitis patients of the Department of Periodontology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt/Main. Each control is matched to one of the respective cases for sex, age (±5 years), self-reported smoking status (current smoker/non-smoker), number of remaining teeth (±2 teeth), and periodontal diagnosis (gingivitis, chronic or aggressive periodontitis).



Primary Outcome Measures :
  1. Gingival Bleeding Index (GBI) [ Time Frame: cross-sectional: only one assessment ]
    A periodontal probe is gently moved through the gingival sulcus. Bleeding is assessed at 6 sites per tooth (mesio-buccal, buccal, disto-buccal, disto-oral, oral, mesio-oral). The frequency of bleeding sites of the total number of assessed sites is calculated as index.


Secondary Outcome Measures :
  1. Bleeding on Probing (BOP) [ Time Frame: cross-sectional: only one assessment ]
    Using a periodontal probe probing pocket depths (PPD) are assessed with a force of 0.2 N at 6 sites per tooth (mesio-buccal, buccal, disto-buccal, disto-oral, oral, mesio-oral). After 30 seconds bleeding on probing is scored at each site. The frequency of bleeding sites of the total number of assessed sites is calculated as index.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cases with type 2 and 3 VWD consecutively consulting the Haemophilia Centre, Medical Clinic III/Institute for Transfusion medicine, Hospital of the Johann Wolfgang Goethe-University Frankfurt/Main are asked to participate in this study as cases. For each case (VWD) a respective haematologically healthy matched control is recruited from the gingivitis and periodontitis patients of the Department of Periodontology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt/Main.
Criteria

Inclusion Criteria von Willebrand Patients:

  • 18 - 80 years old
  • no other bleeding disorder except 2 and 3 von Willebrand disease

Inclusion Criteria healthy controls:

  • no bleeding disorder
  • no anticoagulative medication

Exclusion Criteria von Willebrand Patients:

- requirement of systemic antibiotics for measures that may cause transitory bacteraemia

Exclusion Criteria healthy controls:

- bleeding disorder


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): NCT03078595


Locations
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Germany
Center for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University
Frankfurt am Main, Hessen, Germany, 60596
Dept. of Periodontology, Center of Dentistry and Oral Medicine, Johann Wolfgang Goethe-University
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Goethe University

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Responsible Party: Peter Eickholz, Head of Periodontology, Goethe University
ClinicalTrials.gov Identifier: NCT03078595     History of Changes
Other Study ID Numbers: 143/15
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Peter Eickholz, Goethe University:
periodontal disease
plaque-induced gingivitis
bleeding on probing
von willebrand disease
gingival bleeding

Additional relevant MeSH terms:
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Hemorrhage
Von Willebrand Diseases
Gingival Hemorrhage
Pathologic Processes
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Oral Hemorrhage
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases