Stroke Clinical Trial
Official title:
The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of
Verified date | January 2020 |
Source | Pomeranian Medical University Szczecin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Methods: 100 consecutive patients with their first ever ischemic stroke were enrolled in the study. 56 randomly selected patients were subjected to stimulation of salivation, the remaining patients were not stimulated. The severity of the neurological condition was assessed using the NIHSS scale on days 1, 3 and 7 of stroke. The incidence of periodontal diseases was classified using the Hall's scale in the 1st day of stroke. On days 1 and 7 of stroke, the concentration of IL-1beta, MMP8, OPG and RANKL in the patients' saliva was assessed using the Elisa technique. At the same time, the level of CRP and the number of leukocytes in the peripheral blood were tested on days 1, 3 and 7 of the stroke, and the incidence of upper respiratory and urinary tract infections was assessed.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 26, 2021 |
Est. primary completion date | April 26, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 48 Years to 80 Years |
Eligibility | Inclusion Criteria: - men and women, - at the age of 48-80, - first-ever stroke, - with symptoms from the anterior cerebral vascularity (basin of the internal carotid artery), - with a significant neurological deficit (minimum 3 points according to the NIH scale) - capable of giving informed consent; Exclusion Criteria: - aphasia, disturbance of consciousness, mental disorders - making it impossible to express informed consent - surgery of the salivary glands - disrupting the secretion of saliva - diseases of the salivary glands that disrupt the secretion of saliva (diabetes, Sjögren's syndrome, state after radiotherapy in the area of the salivary glands) |
Country | Name | City | State |
---|---|---|---|
Poland | Departmen of Neurology | Szczecin | Unii Lubelskiej |
Lead Sponsor | Collaborator |
---|---|
Pomeranian Medical University Szczecin |
Poland,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Neurological assessment using the NIHSS scale | On admission, the patient's neurological status is assessed using the NIHSS scale | day 1 of stroke | |
Other | Neurological assessment using the NIHSS scale | On the third, the patient's neurological status is assessed using the NIHSS scale | day 3 of stroke | |
Other | Neurological assessment using the NIHSS scale | On the seventh day, the patient's neurological status is assessed using the NIHSS scale | day 7 of stroke | |
Primary | evaluation of saliva parameters od day 1 | On the first day of admission, saliva (2 ml) is collected and the parameters are MMP8 (ng/mL), OPG ( (ng/mL) and RANKL (ng/mL) | day 1 of stroke | |
Primary | evaluation of saliva parameters od day 1 | On the first day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL) | day 1 of stroke | |
Primary | assessment of blood parameters from day 1 | Assessment of CRP(mg/L) in blood on the first day of hospitalization | day 1 of stroke | |
Primary | assessment of blood parameters from day 1 | Assessment of WBC( G/µL)in blood on the first day of hospitalization | day 1 of stroke | |
Secondary | evaluation of saliva parameters- second measurement | On the seventh day of admission, saliva (2 ml) is collected with the parameters MMP8MMP8 (ng/mL), OPG ( (ng/mL) and RANKL (ng/mL) | day 7 of stroke | |
Secondary | evaluation of saliva parameters- second measurement | On the seven day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL) | day 7 of stroke | |
Secondary | assessment of blood parameters from day 7 | Assessment of CRP(mg/L) in blood on the seven day of hospitalization | day 7 of stroke | |
Secondary | assessment of blood parameters from day 7 | Assessment of WBC( G/µL)in blood on the seven day of hospitalization | day 7 of stroke |
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