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Periodontal DiseasesNCT05394090

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

A study testing saliva stimulation in people with Periodontal Diseases and Saliva Altered, run by Pomeranian Medical University Szczecin at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 48 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases, Saliva Altered, Stroke
What is being tested?
saliva stimulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePoland
Study dates
24 Jan 2020to 26 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 48 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Departmen of Neurology

    Szczecin, Unii Lubelskiej, 71-228

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
saliva stimulation
Medical subject headings
Periodontal Diseases, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • saliva stimulationDiagnostic test

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

Study groups in NCT05394090
Study groupRoleWhat they receive
saliva-stimulated groupExperimentalIn 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.
Receives: Diagnostic Test: saliva stimulation
the group in which the saliva was not stimulatedNo interventionThere was no saliva in the group of 50 patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: day 1 of stroke

  2. 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)

    Measured: day 1 of stroke

  3. assessment of blood parameters from day 1

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

    Measured: day 1 of stroke

  4. assessment of blood parameters from day 1

    Assessment of WBC( G/µL)in blood on the first day of hospitalization

    Measured: day 1 of stroke

Secondary outcomes (4)

  1. 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)

    Measured: day 7 of stroke

  2. evaluation of saliva parameters- second measurement

    On the seven day of admission, saliva (2 ml) is collected and the parameter IL-1Beta(pg/mL)

    Measured: day 7 of stroke

  3. assessment of blood parameters from day 7

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

    Measured: day 7 of stroke

  4. assessment of blood parameters from day 7

    Assessment of WBC( G/µL)in blood on the seven day of hospitalization

    Measured: day 7 of stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start24 Jan 2020
  3. Primary completion26 Apr 2021
  4. Study completion26 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394090
Sponsor's protocol ID
Pomeranian Medical University
Status last verified
Jan 2020
First submitted
16 May 2022
Last updated
27 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 16298220

  • 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.

    PubMed 19774803

  • 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.

    PubMed 10728977

  • 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.

    PubMed 24348618

  • 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.

    PubMed 14707235

  • 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.

    PubMed 23278448

  • 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.

    PubMed 25014033

  • 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.

    PubMed 20732683

  • 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.

    PubMed 18294231

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

    PubMed 11107570

Questions about this trial

What is this clinical trial studying?

A study testing saliva stimulation in people with Periodontal Diseases and Saliva Altered, run by Pomeranian Medical University Szczecin at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

evaluation of saliva parameters od day 1 (time frame: day 1 of stroke). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05394090, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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