Trial Outcomes & Findings for Gingival Bleeding and Von Willebrand Disease Typ 2 and 3 (NCT NCT03078595)
NCT ID: NCT03078595
Last Updated: 2020-02-27
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
48 participants
Primary outcome timeframe
cross-sectional: only one assessment at the time of examination
Results posted on
2020-02-27
Participant Flow
At the Haemophilia Centre, Medical Clinic III/Institute for Transfusion Medicine, Hospital of the Johann Wolfgang Goethe-University Frankfurt/Main approximately 1500 charts of VWD patients were screened rendering about 35 patients with VWD type 2 and 3.
From July 16, 2015 to July 15, 2016 24 type 2 and 3 VWD cases were enrolled. Due to the difficulty to find more type 2 and 3 VWD patients willing to participate recruitment was stopped in March 2017 after enrolment of 24 individuals. From April 04, 2016 to March 24, 2017 24 patients that self-reported to be hematologically healthy were enrolled.
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Von Willebrand Disease Type 2 and 3
n=24 Participants
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
n=24 Participants
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).
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Von Willebrand antigen
|
44 percent
STANDARD_DEVIATION 45.9 • n=24 Participants
|
122.1 percent
STANDARD_DEVIATION 47.2 • n=24 Participants
|
83.0 percent
STANDARD_DEVIATION 60.6 • n=48 Participants
|
|
Von Willebrand activity
|
24.7 percent
STANDARD_DEVIATION 23.4 • n=24 Participants
|
122.1 percent
STANDARD_DEVIATION 45.1 • n=24 Participants
|
73.4 percent
STANDARD_DEVIATION 60.7 • n=48 Participants
|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 11.8 • n=24 Participants
|
46.6 years
STANDARD_DEVIATION 12.4 • n=24 Participants
|
46.3 years
STANDARD_DEVIATION 12.0 • n=48 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=24 Participants
|
17 Participants
n=24 Participants
|
34 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=24 Participants
|
7 Participants
n=24 Participants
|
14 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Number of teeth
|
26.7 number of teeth
STANDARD_DEVIATION 2.9 • n=24 Participants
|
26.8 number of teeth
STANDARD_DEVIATION 2.2 • n=24 Participants
|
26.7 number of teeth
STANDARD_DEVIATION 2.5 • n=48 Participants
|
|
current smokers
|
7 participants
n=24 Participants
|
7 participants
n=24 Participants
|
14 participants
n=48 Participants
|
|
exhaled carbon monoxide (CO)
|
3.9 ppm
STANDARD_DEVIATION 4.6 • n=24 Participants
|
2.8 ppm
STANDARD_DEVIATION 3.4 • n=24 Participants
|
3.4 ppm
STANDARD_DEVIATION 4.0 • n=48 Participants
|
|
Pack years (1 pack-year is equal to smoking 20 cigarettes (1 pack) per day for 1 year)
|
3.3 pack years
STANDARD_DEVIATION 6.4 • n=24 Participants
|
1.6 pack years
STANDARD_DEVIATION 2.9 • n=24 Participants
|
2.4 pack years
STANDARD_DEVIATION 5.0 • n=48 Participants
|
|
Body weight
|
71.6 kg
STANDARD_DEVIATION 16.1 • n=24 Participants
|
68.5 kg
STANDARD_DEVIATION 9.8 • n=24 Participants
|
70.0 kg
STANDARD_DEVIATION 13.3 • n=48 Participants
|
|
HbA1C
|
5.1 percent of gycated hemoglobin
STANDARD_DEVIATION 0.6 • n=24 Participants
|
5 percent of gycated hemoglobin
STANDARD_DEVIATION 0.4 • n=24 Participants
|
5.1 percent of gycated hemoglobin
STANDARD_DEVIATION 0.5 • n=48 Participants
|
|
Gingivitis
|
11 participants
n=24 Participants
|
11 participants
n=24 Participants
|
22 participants
n=48 Participants
|
|
generalized mild, localized moderate chronic periodontitis
|
5 participants
n=24 Participants
|
5 participants
n=24 Participants
|
10 participants
n=48 Participants
|
|
generalized mild, localized severe chronic periodontitis
|
3 participants
n=24 Participants
|
3 participants
n=24 Participants
|
6 participants
n=48 Participants
|
|
generalized moderate chronic periodontitis
|
2 participants
n=24 Participants
|
2 participants
n=24 Participants
|
4 participants
n=48 Participants
|
|
generalized moderate localized severe chronic periodontitis
|
3 participants
n=24 Participants
|
3 participants
n=24 Participants
|
6 participants
n=48 Participants
|
|
Factor VIII
|
55.6 percent
STANDARD_DEVIATION 46.3 • n=24 Participants
|
129.8 percent
STANDARD_DEVIATION 27.5 • n=24 Participants
|
92.7 percent
STANDARD_DEVIATION 53.2 • n=48 Participants
|
|
Plaque Control Record
|
53 percent
STANDARD_DEVIATION 24.1 • n=24 Participants
|
49.5 percent
STANDARD_DEVIATION 15.9 • n=24 Participants
|
51.3 percent
STANDARD_DEVIATION 20.3 • n=48 Participants
|
|
activated matrix metalloproteinase 8 (aMMP8)
|
8 participants
n=24 Participants
|
8 participants
n=24 Participants
|
16 participants
n=48 Participants
|
|
Probing Pocket Depth
|
1.8 mm
STANDARD_DEVIATION 0.6 • n=24 Participants
|
1.9 mm
STANDARD_DEVIATION 0.5 • n=24 Participants
|
1.9 mm
STANDARD_DEVIATION 0.6 • n=48 Participants
|
|
vertical Probing Attachment Level
|
1.9 mm
STANDARD_DEVIATION 0.7 • n=24 Participants
|
1.8 mm
STANDARD_DEVIATION 1.9 • n=24 Participants
|
1.9 mm
STANDARD_DEVIATION 0.6 • n=48 Participants
|
|
Sum of probing pocket depth (PPD)
|
295 mm
STANDARD_DEVIATION 102.6 • n=24 Participants
|
306.7 mm
STANDARD_DEVIATION 87.6 • n=24 Participants
|
300.8 mm
STANDARD_DEVIATION 94.5 • n=48 Participants
|
|
Sum of PPD with BOP
|
54.4 mm
STANDARD_DEVIATION 37.8 • n=24 Participants
|
49.7 mm
STANDARD_DEVIATION 28.1 • n=24 Participants
|
52.1 mm
STANDARD_DEVIATION 33.0 • n=48 Participants
|
|
Periodontal inflamed surface area
|
154.4 mm²
STANDARD_DEVIATION 124 • n=24 Participants
|
136.1 mm²
STANDARD_DEVIATION 95.3 • n=24 Participants
|
145.3 mm²
STANDARD_DEVIATION 109.8 • n=48 Participants
|
|
PPD < 4 mm
|
98.5 percent of sites
STANDARD_DEVIATION 3.8 • n=24 Participants
|
98.7 percent of sites
STANDARD_DEVIATION 3.4 • n=24 Participants
|
98.6 percent of sites
STANDARD_DEVIATION 3.6 • n=48 Participants
|
|
PPD 4 to 6.8 mm
|
1.5 percent
STANDARD_DEVIATION 3.8 • n=24 Participants
|
1.3 percent
STANDARD_DEVIATION 3.4 • n=24 Participants
|
1.4 percent
STANDARD_DEVIATION 3.6 • n=48 Participants
|
PRIMARY outcome
Timeframe: cross-sectional: only one assessment at the time of examinationUsing 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.
Outcome measures
| Measure |
Von Willebrand Disease Type 2 and 3
n=24 Participants
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
n=24 Participants
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).
|
|---|---|---|
|
Bleeding on Probing (BOP)
|
14.5 percentage of sites
Standard Deviation 10.1
|
12.3 percentage of sites
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: cross-sectional: only one assessment at the time of examinationA 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.
Outcome measures
| Measure |
Von Willebrand Disease Type 2 and 3
n=24 Participants
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
n=24 Participants
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).
|
|---|---|---|
|
Gingival Bleeding Index (GBI)
|
10.5 percentage of sites
Standard Deviation 9.9
|
8.8 percentage of sites
Standard Deviation 4.8
|
Adverse Events
Von Willebrand Disease Type 2 and 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Dr. med. dent. Peter Eickholz
Johann Wolfgang Goethe-University Frankfurt
Phone: +4915112433230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place