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

NCT05394090 | Completed

• 1 other identifier: Pomeranian Medical University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Saliva Altered; Stroke

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• assessment of blood parameters from day 1

  Assessment of CRP(mg/L) in blood on the first day of hospitalization

  day 1 of stroke

• 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 Outcomes (4)

• evaluation of saliva parameters- second measurement

  day 7 of stroke

• evaluation of saliva parameters- second measurement

  day 7 of stroke

• assessment of blood parameters from day 7

  day 7 of stroke

• assessment of blood parameters from day 7

  day 7 of stroke

Other Outcomes (3)

• Neurological assessment using the NIHSS scale

  day 1 of stroke

• Neurological assessment using the NIHSS scale

  day 3 of stroke

• Neurological assessment using the NIHSS scale

  day 7 of stroke

Study Arms (2)

saliva-stimulated group

EXPERIMENTAL

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.

Diagnostic Test: saliva stimulation

the group in which the saliva was not stimulated

NO INTERVENTION

There was no saliva in the group of 50 patients

Interventions

saliva stimulation DIAGNOSTIC_TEST

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

saliva-stimulated group

Eligibility Criteria

• Age: 48 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Departmen of Neurology

Szczecin, Unii Lubelskiej, 71-228, Poland

Location

Related Publications (10)

• Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. doi: 10.1016/S0140-6736(05)67728-8.

  PMID: 16298220 BACKGROUND

• 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.

  PMID: 19774803 BACKGROUND

• 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.

  PMID: 10728977 BACKGROUND

• 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.

  PMID: 24348618 BACKGROUND

• 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.

  PMID: 14707235 BACKGROUND

• 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.

  PMID: 23278448 BACKGROUND

• 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.

  PMID: 25014033 BACKGROUND

• 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.

  PMID: 20732683 BACKGROUND

• 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.

  PMID: 18294231 BACKGROUND

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

  PMID: 11107570 RESULT

MeSH Terms

Conditions

Periodontal Diseases; Stroke

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wioletta W Pawlukowska, dr hab.

  Department of Neurology, Pomeranian Medical University, Szczecin, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 27, 2022
• Study Start: January 24, 2020
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: May 27, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)