The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of Ischemic Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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The course of an ischemic stroke varies by many factors. The influence of periodontal diseases and the stimulation of salivation on the course and difficulty of stroke remains unresolved. 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.

Official Title
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The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of

Conditions
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Periodontal Diseases, Saliva Altered, Stroke

Intervention / Treatment
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* Diagnostic Test: saliva stimulation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: saliva-stimulated group<br>In approximately 50 randomly selected patients (group 1), from the second day of admission until the end of hospitalization, a 15-minute manual stimulation of the submandibular and sublingual bib was performed internally and externally. In addition, oral hygiene was performed in patients, taking into account the tongue and cheeks. | Diagnostic Test: saliva stimulation<br>* In 50 patients with ischemic stroke, saliva was the option of a neurologopedic massage of choice<br>|
| No Intervention: the group in which the saliva was not stimulated<br>There was no saliva in the group of 50 patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| assessment of blood parameters from day 1 | Assessment of CRP(mg/L) in blood on the first day of hospitalization | day 1 of stroke | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| assessment of blood parameters from day 7 | Assessment of CRP(mg/L) in blood on the seven day of hospitalization | day 7 of stroke | 
| assessment of blood parameters from day 7 | Assessment of WBC( G/µL)in blood on the seven day of hospitalization | day 7 of stroke |