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

Primary Purpose

Periodontal Diseases, Saliva Altered, Stroke

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
saliva stimulation
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontal Diseases

Eligibility Criteria

48 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Departmen of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

saliva-stimulated group

the group in which the saliva was not stimulated

Arm Description

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.

There was no saliva in the group of 50 patients

Outcomes

Primary Outcome Measures

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)
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)
assessment of blood parameters from day 1
Assessment of CRP(mg/L) in blood on the first day of hospitalization
assessment of blood parameters from day 1
Assessment of WBC( G/µL)in blood on the first day of hospitalization

Secondary Outcome Measures

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)
evaluation of saliva parameters- second measurement
On the seven day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL)
assessment of blood parameters from day 7
Assessment of CRP(mg/L) in blood on the seven day of hospitalization
assessment of blood parameters from day 7
Assessment of WBC( G/µL)in blood on the seven day of hospitalization

Full Information

First Posted
May 16, 2022
Last Updated
May 23, 2022
Sponsor
Pomeranian Medical University Szczecin
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1. Study Identification

Unique Protocol Identification Number
NCT05394090
Brief Title
The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of Ischemic Stroke
Official Title
The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
April 26, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pomeranian Medical University Szczecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Saliva Altered, Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saliva-stimulated group
Arm Type
Experimental
Arm Description
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.
Arm Title
the group in which the saliva was not stimulated
Arm Type
No Intervention
Arm Description
There was no saliva in the group of 50 patients
Intervention Type
Diagnostic Test
Intervention Name(s)
saliva stimulation
Intervention Description
In 50 patients with ischemic stroke, saliva was the option of a neurologopedic massage of choice
Primary Outcome Measure Information:
Title
evaluation of saliva parameters od day 1
Description
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)
Time Frame
day 1 of stroke
Title
evaluation of saliva parameters od day 1
Description
On the first day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL)
Time Frame
day 1 of stroke
Title
assessment of blood parameters from day 1
Description
Assessment of CRP(mg/L) in blood on the first day of hospitalization
Time Frame
day 1 of stroke
Title
assessment of blood parameters from day 1
Description
Assessment of WBC( G/µL)in blood on the first day of hospitalization
Time Frame
day 1 of stroke
Secondary Outcome Measure Information:
Title
evaluation of saliva parameters- second measurement
Description
On the seventh day of admission, saliva (2 ml) is collected with the parameters MMP8MMP8 (ng/mL), OPG ( (ng/mL) and RANKL (ng/mL)
Time Frame
day 7 of stroke
Title
evaluation of saliva parameters- second measurement
Description
On the seven day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL)
Time Frame
day 7 of stroke
Title
assessment of blood parameters from day 7
Description
Assessment of CRP(mg/L) in blood on the seven day of hospitalization
Time Frame
day 7 of stroke
Title
assessment of blood parameters from day 7
Description
Assessment of WBC( G/µL)in blood on the seven day of hospitalization
Time Frame
day 7 of stroke
Other Pre-specified Outcome Measures:
Title
Neurological assessment using the NIHSS scale
Description
On admission, the patient's neurological status is assessed using the NIHSS scale
Time Frame
day 1 of stroke
Title
Neurological assessment using the NIHSS scale
Description
On the third, the patient's neurological status is assessed using the NIHSS scale
Time Frame
day 3 of stroke
Title
Neurological assessment using the NIHSS scale
Description
On the seventh day, the patient's neurological status is assessed using the NIHSS scale
Time Frame
day 7 of stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wioletta W Pawlukowska, dr hab.
Organizational Affiliation
Department of Neurology, Pomeranian Medical University, Szczecin, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Departmen of Neurology
City
Szczecin
State/Province
Unii Lubelskiej
ZIP/Postal Code
71-228
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16298220
Citation
Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. doi: 10.1016/S0140-6736(05)67728-8.
Results Reference
background
PubMed Identifier
19774803
Citation
Blaizot A, Vergnes JN, Nuwwareh S, Amar J, Sixou M. Periodontal diseases and cardiovascular events: meta-analysis of observational studies. Int Dent J. 2009 Aug;59(4):197-209.
Results Reference
background
PubMed Identifier
10728977
Citation
Mattila KJ, Asikainen S, Wolf J, Jousimies-Somer H, Valtonen V, Nieminen M. Age, dental infections, and coronary heart disease. J Dent Res. 2000 Feb;79(2):756-60. doi: 10.1177/00220345000790020901.
Results Reference
background
PubMed Identifier
24348618
Citation
Hashemipour MA, Afshar AJ, Borna R, Seddighi B, Motamedi A. Gingivitis and periodontitis as a risk factor for stroke: A case-control study in the Iranian population. Dent Res J (Isfahan). 2013 Sep;10(5):613-9.
Results Reference
background
PubMed Identifier
14707235
Citation
Grau AJ, Becher H, Ziegler CM, Lichy C, Buggle F, Kaiser C, Lutz R, Bultmann S, Preusch M, Dorfer CE. Periodontal disease as a risk factor for ischemic stroke. Stroke. 2004 Feb;35(2):496-501. doi: 10.1161/01.STR.0000110789.20526.9D. Epub 2004 Jan 5.
Results Reference
background
PubMed Identifier
23278448
Citation
Pinho MM, Faria-Almeida R, Azevedo E, Manso MC, Martins L. Periodontitis and atherosclerosis: an observational study. J Periodontal Res. 2013 Aug;48(4):452-7. doi: 10.1111/jre.12026. Epub 2012 Dec 30.
Results Reference
background
PubMed Identifier
25014033
Citation
Orlandi M, Suvan J, Petrie A, Donos N, Masi S, Hingorani A, Deanfield J, D'Aiuto F. Association between periodontal disease and its treatment, flow-mediated dilatation and carotid intima-media thickness: a systematic review and meta-analysis. Atherosclerosis. 2014 Sep;236(1):39-46. doi: 10.1016/j.atherosclerosis.2014.06.002. Epub 2014 Jun 17.
Results Reference
background
PubMed Identifier
20732683
Citation
Carallo C, Fortunato L, de Franceschi MS, Irace C, Tripolino C, Cristofaro MG, Giudice M, Gnasso A. Periodontal disease and carotid atherosclerosis: are hemodynamic forces a link? Atherosclerosis. 2010 Nov;213(1):263-7. doi: 10.1016/j.atherosclerosis.2010.07.025. Epub 2010 Jul 29.
Results Reference
background
PubMed Identifier
18294231
Citation
Paraskevas S, Huizinga JD, Loos BG. A systematic review and meta-analyses on C-reactive protein in relation to periodontitis. J Clin Periodontol. 2008 Apr;35(4):277-90. doi: 10.1111/j.1600-051X.2007.01173.x. Epub 2008 Feb 20.
Results Reference
background
PubMed Identifier
11107570
Citation
Czlonkowska A, Ryglewicz D. [Epidemiology of cerebral stroke in Poland]. Neurol Neurochir Pol. 1999;32 Suppl 6:99-103. Polish.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://www.pum.edu.pl

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

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