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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394090
• Other study ID #: Pomeranian Medical University
• Status: Completed
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: April 26, 2021

Study information

• Verified date: January 2020
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 48 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Periodontal Diseases
• Saliva Altered
• Stroke

Intervention

Diagnostic Test:
• saliva stimulation
In 50 patients with ischemic stroke, saliva was the option of a neurologopedic massage of choice

Locations

Country	Name	City	State
Poland	Departmen of Neurology	Szczecin	Unii Lubelskiej

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

References & Publications (10)

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. Review. — View 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. — View Citation

Czlonkowska A, Ryglewicz D. [Epidemiology of cerebral stroke in Poland]. Neurol Neurochir Pol. 1999;32 Suppl 6:99-103. Review. Polish. — View Citation

Grau AJ, Becher H, Ziegler CM, Lichy C, Buggle F, Kaiser C, Lutz R, Bültmann S, Preusch M, Dörfer CE. Periodontal disease as a risk factor for ischemic stroke. Stroke. 2004 Feb;35(2):496-501. Epub 2004 Jan 5. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurological assessment using the NIHSS scale	On admission, the patient's neurological status is assessed using the NIHSS scale	day 1 of stroke
Other	Neurological assessment using the NIHSS scale	On the third, the patient's neurological status is assessed using the NIHSS scale	day 3 of stroke
Other	Neurological assessment using the NIHSS scale	On the seventh day, the patient's neurological status is assessed using the NIHSS scale	day 7 of stroke
Primary	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)	day 1 of stroke
Primary	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)	day 1 of stroke
Primary	assessment of blood parameters from day 1	Assessment of CRP(mg/L) in blood on the first day of hospitalization	day 1 of stroke
Primary	assessment of blood parameters from day 1	Assessment of WBC( G/µL)in blood on the first day of hospitalization	day 1 of stroke
Secondary	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)	day 7 of stroke
Secondary	evaluation of saliva parameters- second measurement	On the seven day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL)	day 7 of stroke
Secondary	assessment of blood parameters from day 7	Assessment of CRP(mg/L) in blood on the seven day of hospitalization	day 7 of stroke
Secondary	assessment of blood parameters from day 7	Assessment of WBC( G/µL)in blood on the seven day of hospitalization	day 7 of stroke