NCT05418335

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 12, 2022

Status Verified

June 1, 2022

Enrollment Period

3 days

First QC Date

June 10, 2022

Last Update Submit

October 10, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    Baseline

  • DMFT Index (Decayed-Missing-Filled-Teeth )

    It shows the number of decayed teeth, filled teeth and teeth extracted due to caries per capita

    Baseline

  • Periodontal Disease Index

    The mesial, distal, facial and lingual areas of each of the teeth are evaluated.

    Baseline

Secondary Outcomes (3)

  • Beck Depression Inventory

    Baseline

  • Plaque Index

    Baseline

  • Gingival Index

    Baseline

Study Arms (2)

stroke group

stroke history at least 3 months ago

Other: Clinical examination, functional status evaluation

Control group

Healthy control

Other: Clinical examination, functional status evaluation

Interventions

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 groupstroke group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Having a history of ischemic stroke at least 3 months
  • Age between 50-75

You may not qualify if:

  • The patient has moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elif Yakşi

Merkez, Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeMouth DiseasesVitamin D Deficiency

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStomatognathic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 14, 2022

Study Start

July 12, 2022

Primary Completion

July 15, 2022

Study Completion

October 1, 2022

Last Updated

October 12, 2022

Record last verified: 2022-06

Locations