The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of Ischemic Stroke
NCT ID: NCT05394090
Last Updated: 2022-05-27
Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-01-24
2021-04-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
saliva stimulation
In 50 patients with ischemic stroke, saliva was the option of a neurologopedic massage of choice
the group in which the saliva was not stimulated
There was no saliva in the group of 50 patients
No interventions assigned to this group
Interventions
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saliva stimulation
In 50 patients with ischemic stroke, saliva was the option of a neurologopedic massage of choice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
48 Years
80 Years
ALL
Yes
Sponsors
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Pomeranian Medical University Szczecin
OTHER
Responsible Party
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Principal Investigators
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Wioletta W Pawlukowska, dr hab.
Role: STUDY_CHAIR
Department of Neurology, Pomeranian Medical University, Szczecin, Poland
Locations
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Departmen of Neurology
Szczecin, Unii Lubelskiej, Poland
Countries
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References
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Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. doi: 10.1016/S0140-6736(05)67728-8.
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.
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.
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.
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.
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.
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.
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.
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.
Czlonkowska A, Ryglewicz D. [Epidemiology of cerebral stroke in Poland]. Neurol Neurochir Pol. 1999;32 Suppl 6:99-103. Polish.
Study Documents
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Document Type: Individual Participant Data Set
View DocumentOther Identifiers
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Pomeranian Medical University
Identifier Type: -
Identifier Source: org_study_id
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