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NCT Number: NCT05394090

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

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.

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Key information

Conditions

Periodontal Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mouth Diseases Nervous System Diseases Saliva Altered Stomatognathic Diseases Stroke Vascular Diseases

Age range

48 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departmen of Neurology

Szczecin, Unii Lubelskiej, 71-228, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

saliva stimulation

Diagnostic Test

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

Primary outcomes

  1. evaluation of saliva parameters od day 1

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: day 1 of stroke

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

Secondary outcomes

  1. evaluation of saliva parameters- second measurement

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: day 7 of stroke

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

Other outcomes

  1. Neurological assessment using the NIHSS scale

    Time frame: day 1 of stroke

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

  2. Neurological assessment using the NIHSS scale

    Time frame: 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

    Time frame: day 7 of stroke

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

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 27, 2022
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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