- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05418335
Oral Health and Vitamin D in Stroke Patients
Investigation of the Effects of Vitamin D Levels on Oral Health in Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bolu
-
Merkez, Bolu, Turkey, 14030
- Elif Yakşi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Having a history of ischemic stroke at least 3 months
- Age between 50-75
Exclusion Criteria:
- The patient has moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
stroke group
stroke history at least 3 months ago
|
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
|
|
Control group
Healthy control
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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. |
Baseline
|
|
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
|
Baseline
|
|
Periodontal Disease Index
Time Frame: Baseline
|
The mesial, distal, facial and lingual areas of each of the teeth are evaluated.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory
Time Frame: Baseline
|
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)
|
Baseline
|
|
Plaque Index
Time Frame: Baseline
|
It is used to evaluate the level and rate of plaque formation on tooth surfaces
|
Baseline
|
|
Gingival Index
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-EY-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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