Clinical Trial: Gingival Bleeding and Von Willebrand Disease Typ 2 and 3

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Is Gingival Bleeding a Symptom of Patients With Type 2 and 3 Von Willebrand Disease? A Case-Control Study

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.

Detailed Summary:

Patients

All patients 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. They are asked for bleeding and subjective symptoms indicating periodontal disease.

The study complies with the rules of the Declaration of Helsinki and was approved by the Institutional Review Board for Human Studies of the Medical Faculty of the Goethe-University Frankfurt/Main (Application# 143/15). All participating individuals are informed on risks and benefits as well as the procedures of the study and give written informed consent.

Controls

For each case (VWD) a respective hematologically 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).

All participants are asked about current and past cigarette smoking habits. Patients who report smoking or have quit smoking for less than five years are classified as smokers. Additionally the amount of carbon monoxide (CO) in exhaled air is measured using a device (Bedfont Smokerlyzer; Bedfont Scientific Ltd, Rochester, Great Britain).

Hematologic examinations

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.