NCT06332846

Brief Summary

Maintaining good oral health is essential for general health and quality of life. Results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. The aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population. The oral health was assessed in patients with stroke and in (control group). The following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. To assess oral hygiene API (Approximal Plaque Index) was used. As part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to Hall and Sulcus Bleeding Index during probing (SBI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

March 1, 2024

Last Update Submit

March 22, 2024

Conditions

Keywords

strokeoral healthdentitionperiodontium

Outcome Measures

Primary Outcomes (5)

  • Oral health status

    The study aimed to estimate and compare a condition of oral health in stroke patients during hospital stay and healthy individuals.The following elements were assessed: a number of missing teeth, active caries foci and existing fillings. Each tooth was evaluated and scored as sound, decayed (DT), extracted because of the carious pro-cess (MT), or filled due to caries (FT). The data obtained from the examination were used to calculate the DMFT index, which is the sum of DT, MT and FT, and expresses dental caries experience.

    Baseline

  • Oral hygiene assessment

    Value of API is determined in percentage, according to proportion of the number of interproximal areas with plaque to number of all assessed interproximal areas.API values between 100-70% indicate the improper oral hygiene, values between 70-40% indicate an average oral hygiene, values between 39-25% indicate quite good hygiene, and values below 25% indicate optimal oral hygiene.

    Baseline

  • Periodontal status- periodontal pockets

    The depth of the existing periodontal pockets in mm (up to 3mm, 3-6 mm, above 6 mm).

    Baseline

  • Periodontal status-tooth mobility

    Tooth mobility according to Hall (0- no mobility, 1- labio-lingual mobility up to 1mm, 2- labio-lingual mobility up to 2 mm, 3- labio-lingual and vertical mobility).

    Baseline

  • Periodontal status- bleeding

    Sulcus Bleeding Index during probing (SBI). SBI is an index of gingival inflammation in which bleeding is measured from four gingival units (mesial and distal papillary units and labial and lingual marginal units) using a periodontal probe with a 0,5 mm diameter tip. The scoring range around eight anterior teeth (four maxillary and four mandibular) is from 0 (healthy appearance and no bleeding on probing to 5 (spontaneous bleeding with marked swelling and change in colour).

    Baseline

Study Arms (2)

study group

The study group consisted of 59 individuals subjects with a first ischemic stroke, with symptoms from the anterior cerebral artery (basin of the internal carotid artery), with a significant neurological deficit (minimum 3 points according to National Institute of Health Stroke Scale

Other: oral examination

control group

The control group (59 individuals) matched for age and gender was selected among patients of the Department of Interdisciplinary Dentistry at Pomeranian Medical University in Szczecin.

Other: oral examination

Interventions

The oral health was assessed in each patient enrolled in the study. The examination was performed by using dental mirror and a calibrated periodontal probe in a day ight

Also known as: study group
control group

Eligibility Criteria

Age45 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study group consisted of 59 individuals subjects with a first ischemic stroke, with symptoms from the anterior cerebral artery (basin of the internal carotid artery), with a significant neurological deficit (minimum 3 points according to National Institute of Health Stroke Scale (NIHSS)). The control group (59 individuals) matched for age and gender was selected among patients of the Department of Interdisciplinary Dentistry at Pomeranian Medical University in Szczecin.

You may qualify if:

  • first ischemic stroke, with symptoms from the anterior cerebral artery (basin of the internal carotid artery), with a significant neurological deficit (minimum 3 points according to National Institute of Health Stroke Scale (NIHSS))

You may not qualify if:

  • aphasia, disturbances of consciousness, mental disorders- making it impossible to express informed consent,
  • surgery of the salivary glands- disrupting the secretion of saliva,
  • diseases that disrupt salivary secretion (diabetes mellitus, Sjogren's syndrome, condition after radio-therapy in the area of the salivary glands)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pomeranian Medical University in Szczecin

Szczecin, 70-111, Poland

Location

MeSH Terms

Conditions

Mouth DiseasesIschemic StrokeStroke

Interventions

Diagnosis, OralControl Groups

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DentistryEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 27, 2024

Study Start

October 10, 2019

Primary Completion

November 15, 2021

Study Completion

December 10, 2023

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations