Clinical trial NCT05394090: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Saliva Altered
Stroke
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 48
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: evaluation of saliva parameters od day 1
timeFrame: day 1 of stroke
measure: evaluation of saliva parameters od day 1
timeFrame: day 1 of stroke
measure: assessment of blood parameters from day 1
timeFrame: day 1 of stroke
measure: assessment of blood parameters from day 1
timeFrame: day 1 of stroke
Secondary outcomes:
measure: evaluation of saliva parameters- second measurement
timeFrame: day 7 of stroke
measure: evaluation of saliva parameters- second measurement
timeFrame: day 7 of stroke
measure: assessment of blood parameters from day 7
timeFrame: day 7 of stroke
measure: assessment of blood parameters from day 7
timeFrame: day 7 of stroke
Other outcomes:
measure: Neurological assessment using the NIHSS scale
timeFrame: day 1 of stroke
measure: Neurological assessment using the NIHSS scale
timeFrame: day 3 of stroke
measure: Neurological assessment using the NIHSS scale
timeFrame: day 7 of stroke
Locations:
city: Szczecin
country: Poland
facility: Departmen of Neurology
state: Unii Lubelskiej
Study officials:
affiliation: Department of Neurology, Pomeranian Medical University, Szczecin, Poland
name: Wioletta W Pawlukowska, dr hab.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: Czlonkowska A, Ryglewicz D. [Epidemiology of cerebral stroke in Poland]. Neurol Neurochir Pol. 1999;32 Suppl 6:99-103. Polish.