- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06332846
Oral Health in Patients Hospitalized Because of Ischemic Stroke
Assessment of Oral Health in Patients Hospitalized Because of Ischemic Stroke
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Szczecin, Poland, 70-111
- Pomeranian Medical University in Szczecin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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))
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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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
Other Names:
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 the artificial lightning
Other Names:
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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.
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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
Other Names:
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 the artificial lightning
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Oral health status
Time Frame: Baseline
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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.
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Baseline
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Oral hygiene assessment
Time Frame: Baseline
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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.
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Baseline
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Periodontal status- periodontal pockets
Time Frame: Baseline
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The depth of the existing periodontal pockets in mm (up to 3mm, 3-6 mm, above 6 mm).
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Baseline
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Periodontal status-tooth mobility
Time Frame: Baseline
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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).
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Baseline
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Periodontal status- bleeding
Time Frame: Baseline
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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).
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KB-0012/06/10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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