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

Sponsor
Pomeranian Medical University Szczecin (Other)
Overall Status
Completed
CT.gov ID
NCT05394090
Collaborator
(none)
50
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2
15
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: saliva stimulation
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of
Actual Study Start Date :
Jan 24, 2020
Actual Primary Completion Date :
Apr 26, 2021
Actual Study Completion Date :
Apr 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: saliva-stimulated group

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
In 50 patients with ischemic stroke, saliva was the option of a neurologopedic massage of choice

No Intervention: the group in which the saliva was not stimulated

There was no saliva in the group of 50 patients

Outcome Measures

Primary Outcome Measures

  1. evaluation of saliva parameters od day 1 [day 1 of stroke]

    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)

  2. evaluation of saliva parameters od day 1 [day 1 of stroke]

    On the first day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL)

  3. assessment of blood parameters from day 1 [day 1 of stroke]

    Assessment of CRP(mg/L) in blood on the first day of hospitalization

  4. assessment of blood parameters from day 1 [day 1 of stroke]

    Assessment of WBC( G/µL)in blood on the first day of hospitalization

Secondary Outcome Measures

  1. evaluation of saliva parameters- second measurement [day 7 of stroke]

    On the seventh day of admission, saliva (2 ml) is collected with the parameters MMP8MMP8 (ng/mL), OPG ( (ng/mL) and RANKL (ng/mL)

  2. evaluation of saliva parameters- second measurement [day 7 of stroke]

    On the seven day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL)

  3. assessment of blood parameters from day 7 [day 7 of stroke]

    Assessment of CRP(mg/L) in blood on the seven day of hospitalization

  4. assessment of blood parameters from day 7 [day 7 of stroke]

    Assessment of WBC( G/µL)in blood on the seven day of hospitalization

Other Outcome Measures

  1. Neurological assessment using the NIHSS scale [day 1 of stroke]

    On admission, the patient's neurological status is assessed using the NIHSS scale

  2. Neurological assessment using the NIHSS scale [day 3 of stroke]

    On the third, the patient's neurological status is assessed using the NIHSS scale

  3. Neurological assessment using the NIHSS scale [day 7 of stroke]

    On the seventh day, the patient's neurological status is assessed using the NIHSS scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
48 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departmen of Neurology Szczecin Unii Lubelskiej Poland 71-228

Sponsors and Collaborators

  • Pomeranian Medical University Szczecin

Investigators

  • Study Chair: Wioletta W Pawlukowska, dr hab., Department of Neurology, Pomeranian Medical University, Szczecin, Poland

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier:
NCT05394090
Other Study ID Numbers:
  • Pomeranian Medical University
First Posted:
May 27, 2022
Last Update Posted:
May 27, 2022
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022