StrokeNCT05418335
Oral Health and Vitamin D in Stroke Patients
An observational study of Stroke and Oral Disease, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Stroke is a common, serious and restrictive global health problem. Restricting the activities of daily living of stroke patients impairs patients' ability to pay attention to oral hygiene. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Oral Disease, D Vitamin Deficiency
- What is being tested?
- Clinical examination, functional status evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2022to 1 Oct 2022
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients and healthy control group will be included in the study.
Who may be able to join
- Having a history of ischemic stroke at least 3 months
- Age between 50-75
Who cannot join
- The patient has moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Vitamin D Levels on Oral Health in Stroke Patients
Stroke is a common, serious and restrictive global health problem. Restricting the activities of daily living of stroke patients impairs patients' ability to pay attention to oral hygiene. Facial paresis and tongue weakness due to stroke may cause a decrease in the control of dental prostheses and the removal of food residues in the oral cavity. Food residues and saliva contaminated with bacteria as a result of poor oral hygiene can result in pneumonia when aspirated due to oropharyngeal dysphagia. In the literature, it has been shown that there are significant relationships between periodontal health and vitamin D and calcium intake, and that dietary supplementation with calcium and vitamin D can improve periodontal health, increase bone mineral density in the mandible, and inhibit alveolar bone resorption. In line with all these data, our hypothesis in this study is to investigate the relationship between oral health and vitamin D levels in stroke patients in rehabilitation units.
Read the detailed description
Stroke is a common, serious and restrictive global health problem. In most countries, stroke is among the second or third most common cause of death and is one of the main causes of acquired disability in adults. Although the first attack is usually not fatal in stroke patients, it can often have long-term consequences for patients and their families. Although notable advances have been made in the medical management of stroke, treatment for most stroke patients is based on care and rehabilitation. Motor, perceptual, and cognitive impairments after stroke can have adverse effects on daily functions, reducing health-related quality of life. Restricting the activities of daily living of stroke patients impairs patients' ability to pay attention to oral hygiene. Facial paresis and tongue weakness due to stroke may cause a decrease in the control of dental prostheses and the removal of food residues in the oral cavity. Food residues and saliva contaminated with bacteria as a result of poor oral hygiene can result in pneumonia when aspirated due to oropharyngeal dysphagia.In addition, reduced tongue pressure fails to push the food bolus into the pharynx. Decreased lip strength causes saliva to flow during chewing. Hyposalivation causes a lack of lubrication in the oral mucosa. Abnormal oral sensory function, rapid and improper swallowing of food causes choking and aspiration, and aspiration pneumonia. Incompatible orofacial function leads to low chewing efficiency, limited food selection, and malnutrition. In addition, the risk of poor periodontal health is associated with stroke recurrence and more severe stroke. Third, severe periodontitis, which leads to decreased bite force and increased tooth mobility during chewing, impairs chewing and food intake, affecting oral health conditions.Vitamin D plays a critical role in mediating calcium absorption and regulating musculoskeletal health.There are reports of the benefit of vitamin D and calcium supplementation in the treatment of periodontal disease. Some previous studies reported that calcium and vitamin D supplementation reduced tooth loss and alveolar bone resorption, but could not reach a clear conclusion because of the heterogeneous composition of the study groups or because it did not directly measure periodontal disease status. More recent studies have shown that there are significant associations between periodontal health and the intake of vitamin D and calcium, and that dietary supplementation with calcium and vitamin D can improve periodontal health, increase bone mineral density in the mandible, and inhibit alveolar bone resorption. In line with all these data, our hypothesis in this study is to investigate the relationship between oral health and vitamin D levels in stroke patients in rehabilitation units.
- Conditions
- Stroke, Oral Disease, D Vitamin Deficiency
- Being tested
- Clinical examination, functional status evaluation
- Medical subject headings
- Stroke, Mouth Diseases, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination, functional status evaluationOther
Barthel Index, Oral Health Impact Profile 14, Beck Depression Inventory, Stroke Impact Scale 3, Plaque Index, Calculus Index, Periodontal Disease Index, Simplified Oral Hygiene Index assesment, DMFT Index
| Study group | Role | What they receive |
|---|---|---|
| stroke group | stroke history at least 3 months ago Receives: Other: Clinical examination, functional status evaluation | |
| Control group | Healthy control Receives: Other: Clinical examination, functional status evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index
It is a simple, understandable index that includes all the parameters of daily living activities. It consists of 10 sub-headings: eating, bathing, self-care, dressing, bladder control, bowel control, toilet use, chair/bed transfer, mobility, and use of stairs. Its scoring ranges from 0-100.
Measured: Baseline
Oral Health Impact Profile -14
Oral health-related quality of life is the individual's personal perception of how oral health affects their quality of life and general health. Oral health impact profile is a scale system that evaluates this perception with two questions on functional limitation, physical pain, psychological discomfort, physical, psychological and social disability and handicap. It is concluded that as the total score increases, the severity of the problem increases and the quality of life decreases.
It is a scale that evaluates oral health-related quality of life with a questionnaire consisting of a total of 14 questions and 7 sub-headings (functional limitation, physical pain, psychological discomfort, physical, psychological and social disability and disability).
Each item is scored as 0 (never), 1 (hardly ever), 2 (occasionally), 3 (fairly often), 4 (very often). High score indicates reduced quality of life15.
Measured: Baseline
DMFT Index (Decayed-Missing-Filled-Teeth )
It shows the number of decayed teeth, filled teeth and teeth extracted due to caries per capita
Measured: Baseline
Periodontal Disease Index
The mesial, distal, facial and lingual areas of each of the teeth are evaluated.
Measured: Baseline
Secondary outcomes (3)
Beck Depression Inventory
It is used to measure physical, emotional and cognitive symptoms such as hopelessness, irritability, guilt, fatigue, and weight loss encountered in depression, was used for evaluation. Scoring in BDI is evaluated progressively from absence of symptoms to severe symptoms. Total score ranged from 0 (no depression) to 63 points (severe depression)
Measured: Baseline
Plaque Index
It is used to evaluate the level and rate of plaque formation on tooth surfaces
Measured: Baseline
Gingival Index
Löe \& Silness gingival index values are used to determine gingival inflammation. The mesial, distal, lingual and vestibule gingival conditions of the teeth determined in each sextant are evaluated by scoring between 0-3.Gingival index; grade 0, normal gingiva; grade 1, mild inflammation, slight change in color, slight edema; no bleeding on palpation; grade 2, moderate inflammation, hyperemia, edema, and glazing; bleeding on palpation; grade 3, severe inflammation, marked hyperemia and edema, ulcerations; tendency to spontaneous bleeding.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start12 Jul 2022
- Primary completion15 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif yaksi, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418335
- Sponsor's protocol ID
- AIBU-FTR-EY-06
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Vitamin D Levels on Oral Health in Stroke Patients
- ClinicalTrials.gov ID
- NCT05418335
- Acronym / sponsor ID
- AIBU-FTR-EY-06
- Conditions
- Stroke, Oral Disease, D Vitamin Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 14 Jun 2022 (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.
Stroke is a common, serious and restrictive global health problem. Restricting the activities of daily living of stroke patients impairs patients' ability to pay attention to oral hygiene. Facial paresis and tongue weakness due to stroke may cause a decrease in the control of dental prostheses and the removal of food residues in the oral cavity. Food residues and saliva contaminated with bacteria as a result of poor oral hygiene can result in pneumonia when aspirated due to oropharyngeal dysphagia. In the literature, it has been shown that there are significant relationships between periodontal health and vitamin D and calcium intake, and that dietary supplementation with calcium and vitamin D can improve periodontal health, increase bone mineral density in the mandible, and inhibit alveolar bone resorption. In line with all these data, our hypothesis in this study is to investigate the relationship between oral health and vitamin D levels in stroke patients in rehabilitation units.
Detailed description
Stroke is a common, serious and restrictive global health problem. In most countries, stroke is among the second or third most common cause of death and is one of the main causes of acquired disability in adults. Although the first attack is usually not fatal in stroke patients, it can often have long-term consequences for patients and their families. Although notable advances have been made in the medical management of stroke, treatment for most stroke patients is based on care and rehabilitation. Motor, perceptual, and cognitive impairments after stroke can have adverse effects on daily functions, reducing health-related quality of life. Restricting the activities of daily living of stroke patients impairs patients' ability to pay attention to oral hygiene. Facial paresis and tongue weakness due to stroke may cause a decrease in the control of dental prostheses and the removal of food residues in the oral cavity. Food residues and saliva contaminated with bacteria as a result of poor oral hygiene can result in pneumonia when aspirated due to oropharyngeal dysphagia.In addition, reduced tongue pressure fails to push the food bolus into the pharynx. Decreased lip strength causes saliva to flow during chewing. Hyposalivation causes a lack of lubrication in the oral mucosa. Abnormal oral sensory function, rapid and improper swallowing of food causes choking and aspiration, and aspiration pneumonia. Incompatible orofacial function leads to low chewing efficiency, limited food selection, and malnutrition. In addition, the risk of poor periodontal health is associated with stroke recurrence and more severe stroke. Third, severe periodontitis, which leads to decreased bite force and increased tooth mobility during chewing, impairs chewing and food intake, affecting oral health conditions.Vitamin D plays a critical role in mediating calcium absorption and regulating musculoskeletal health.There are reports of the benefit of vitamin D and calcium supplementation in the treatment of periodontal disease. Some previous studies reported that calcium and vitamin D supplementation reduced tooth loss and alveolar bone resorption, but could not reach a clear conclusion because of the heterogeneous composition of the study groups or because it did not directly measure periodontal disease status. More recent studies have shown that there are significant associations between periodontal health and the intake of vitamin D and calcium, and that dietary supplementation with calcium and vitamin D can improve periodontal health, increase bone mineral density in the mandible, and inhibit alveolar bone resorption. In line with all these data, our hypothesis in this study is to investigate the relationship between oral health and vitamin D levels in stroke patients in rehabilitation units.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke group | – | Other: Clinical examination, functional status evaluationstroke history at least 3 months ago |
| Control group | – | Other: Clinical examination, functional status evaluationHealthy control |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients and healthy control group will be included in the study.
Key inclusion criteria (2 listed)
- Having a history of ischemic stroke at least 3 months
- Age between 50-75
Key exclusion criteria (1 listed)
- The patient has moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment.
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 |
|---|---|---|
| Clinical examination, functional status evaluationBarthel Index, Oral Health Impact Profile 14, Beck Depression Inventory, Stroke Impact Scale 3, Plaque Index, Calculus Index, Periodontal Disease Index, Simplified Oral Hygiene Index assesment, DMFT Index | Other | Control group, stroke group |
Primary outcome
Barthel Index
Time frame: Baseline
It is a simple, understandable index that includes all the parameters of daily living activities. It consists of 10 sub-headings: eating, bathing, self-care, dressing, bladder control, bowel control, toilet use, chair/bed transfer, mobility, and use of stairs. Its scoring ranges from 0-100.
Oral Health Impact Profile -14
Time frame: Baseline
Oral health-related quality of life is the individual's personal perception of how oral health affects their quality of life and general health. Oral health impact profile is a scale system that evaluates this perception with two questions on functional limitation, physical pain, psychological discomfort, physical, psychological and social disability and handicap. It is concluded that as the total score increases, the severity of the problem increases and the quality of life decreases. It is a scale that evaluates oral health-related quality of life with a questionnaire consisting of a total of 14 questions and 7 sub-headings (functional limitation, physical pain, psychological discomfort, physical, psychological and social disability and disability). Each item is scored as 0 (never), 1 (hardly ever), 2 (occasionally), 3 (fairly often), 4 (very often). High score indicates reduced quality of life15.
DMFT Index (Decayed-Missing-Filled-Teeth )
Time frame: Baseline
It shows the number of decayed teeth, filled teeth and teeth extracted due to caries per capita
Periodontal Disease Index
Time frame: Baseline
The mesial, distal, facial and lingual areas of each of the teeth are evaluated.
3 secondary outcomes
Beck Depression Inventory
Time frame: Baseline
Plaque Index
Time frame: Baseline
Gingival Index
Time frame: Baseline
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 12 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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 Stroke and Oral Disease, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 12 Oct 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 Turkey (Türkiye). 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?
Barthel Index (time frame: Baseline). 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?
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 12 Oct 2022.