Oral Health and Vitamin D in Stroke Patients

October 10, 2022 updated by: Elif yaksi, Abant Izzet Baysal University

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bolu
      • Merkez, Bolu, Turkey, 14030
        • Elif Yakşi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Stroke patients and healthy control group will be included in the study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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