Oral DiseaseNCT06332846
Oral Health in Patients Hospitalized Because of Ischemic Stroke
An observational study of Oral Disease and Stroke, Ischemic, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 89 years
- Conditions the study is for
- Oral Disease, Stroke, Ischemic
- What is being tested?
- oral examination
- Type of treatment
- Pill or oral medicine
- How many people
- 118 participants
- Where
- 1 sitePoland
- Study dates
- 10 Oct 2019to 10 Dec 2023
- Phase
- Observational
- 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 45 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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))
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Oral Disease, Stroke, Ischemic
- Being tested
- oral examination
- Keywords
- stroke, oral health, dentition, periodontium
- Medical subject headings
- Mouth Diseases, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral examinationOther
Also called study group
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
oral examinationOther
Also called control group
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: oral examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Periodontal status- periodontal pockets
The depth of the existing periodontal pockets in mm (up to 3mm, 3-6 mm, above 6 mm).
Measured: 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).
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start10 Oct 2019
- Primary completion15 Nov 2021
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332846
- Sponsor's protocol ID
- KB-0012/06/10
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oral Health in Patients Hospitalized Because of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06332846
- Acronym / sponsor ID
- KB-0012/06/10
- Conditions
- Oral Disease, Stroke, Ischemic
- Keywords
- stroke, oral health, dentition, periodontium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: oral examinationThe 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 |
| control group | – | Other: oral examinationThe 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. |
Who may qualify
- Ages
- 45 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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))
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral examinationAlso: study groupThe 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 | control group |
| oral examinationAlso: control groupThe 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 | study group |
Primary outcome
Oral health status
Time frame: Baseline
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.
Oral hygiene assessment
Time frame: Baseline
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.
Periodontal status- periodontal pockets
Time frame: Baseline
The depth of the existing periodontal pockets in mm (up to 3mm, 3-6 mm, above 6 mm).
Periodontal status-tooth mobility
Time frame: Baseline
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).
Periodontal status- bleeding
Time frame: Baseline
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Disease and Stroke, Ischemic, 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 1 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 Mar 2024. 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?
Oral health status (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2024.