Oral Health Intervention in Hemodialysis Patients

March 10, 2026 updated by: Sevda Ateş, Çanakkale Onsekiz Mart University

The Effect of Oral Care Education and Reminder Cards on Patients Receiving Hemodialysis Treatment: A Quasi-experimental Study

Preserving dental health in patients undergoing hemodialysis is crucial for enhancing quality of life. Nonetheless, interventions pertaining to oral health have not been adequately studied. The impact of a simultaneous intervention comprising oral health education and reminder cards remains ambiguous. The findings help to examine the effect of oral health interventions on the levels of oral health and chronic disease adherence in patients receiving hemodialysis treatment. The use of oral care education, reminder cards, and checklists related to oral health can prevent the neglect of oral care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Preserving dental health in patients undergoing hemodialysis is crucial for enhancing quality of life. Nonetheless, interventions pertaining to oral health have not been adequately studied. The aim is to investigate the impact of oral care education and reminder cards concerning oral health on the oral health and illness adaptation of persons undergoing hemodialysis. The study employed a quasi-experimental design with a single group, utilising pre-test and post-test measurements. The study included 82 individuals (aged ≥ 18 years) receiving treatment in the hemodialysis units of two different hospitals in Turkey. Sociodemographic and clinical information was obtained from medical records. The "Adaptation to Chronic Illness Scale" and the "Oral Assessment Guide" were employed to assess oral health and illness adaptation. A one-week intervention was conducted, using daily oral health reminder cards following oral care teaching. A significant difference was found between the mean oral health and illness adaptation levels in the pre-test (15.51±2.67; 84.37±9.14, respectively) and post-test (12.61±3.83; 86.26±9.66, respectively) scores (p=0.00). Oral health and treatment adherence were better after the use of oral care education and reminder cards (p=0.00). Daily tooth brushing frequency was a common factor influencing oral health and chronic disease adherence levels (p<0.05). The mean scores for oral health and illness adaptation were moderately and negatively correlated before and after the intervention (sırasıyla r=-0.46, r=-0.52; p<0.01). The findings help to examine the effect of oral health interventions on the levels of oral health and chronic disease adherence in patients receiving hemodialysis treatment. The use of oral care education, reminder cards, and checklists related to oral health can prevent the neglect of oral care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

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

  • Turkey (Türkiye)
      • Çanakkale, Turkey (Türkiye), 17100
        • Department of Nursing, Faculty of Health Sciences, Canakkale Onsekiz Mart University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population consisted of 115 individuals who applied to the hemodialysis unit of a research and practice hospital located in a city centre for hemodialysis treatment between July and October 2024. No sample selection was performed, and 82 (71.30%) patients on hemodialysis who met the inclusion criteria of the research were included in the sample.

Description

Inclusion Criteria:

  • being 18 years of age or older,
  • receiving HD treatment three or four times a week for at least 6 months,
  • having no hearing, visual, or speech impairment,
  • having no diagnosis of malignancy,
  • performing self-oral care,

Exclusion Criteria:

  • Patients who refused to participate in the study,
  • did not meet the inclusion criteria,
  • did not consent to an oral examination,

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
experimental group
Experimental: arm description experimental Arm Description: The socio-demographic and descriptive characteristics and disease adaptation levels included in the survey form were answered through face-to-face interviews. Participants' oral health was assessed. Oral care education was provided. Disease adaptation levels and oral health were assessed one week after the education.
Other: Oral health education
After the pre-test application, one-on-one oral care education, lasting an average of 15 minutes, was conducted for each participant. The content of the education included: oral health in adults; the consequences of poor oral hygiene; points to consider for oral health; demonstration of the brushing technique; coping with care-resistant behaviors; and how to use the oral health reminder card and checklist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oral Assessment Guide
Time Frame: one weeks
The guide allows for the assessment of voice, swallowing, lips, tongue, saliva, mucous membrane, gums, and teeth/dentures. The OAG supports the creation of an oral care protocol for patients with impaired oral mucous membranes. Each change related to oral health is scored between 1 and 3 points, and these scores are summed to obtain the total score. Scores obtainable from the OAG range from 8 to 24. A score between 8 and 14 indicates a "risk of impairment in the oral mucous membrane," while a score between 14 and 24 indicates "impairment in the oral mucous membrane." According to the OAG, a low score indicates good oral health, whereas high scores suggest poor oral health. A light source and a tongue depressor for each participant were used when evaluating oral health.
one weeks
Oral Health Reminder Card
Time Frame: one weeks
The card contains a total of 10 items regarding what should be paid attention to in daily oral health and was prepared based on the literature. The reminder cards were 10x15 cm in size, and participants were asked to place these cards somewhere visible in their homes. The reminder cards were not taken back.
one weeks
Oral Health Checklist
Time Frame: one weeks
This form contains the items listed on the Oral Health Reminder Card. Participants were asked to implement the items on the checklist and mark them as applied. Participants had the opportunity to evaluate whether they performed the oral health items every day over a one-week period.
one weeks
Adaptation to Chronic Illness Scale
Time Frame: one weeks
The scale comprises 25 items across three subdomains, including physical, social, and psychological adjustment. The scale is designed as a 5-point Likert scale (with 1 = Strongly Disagree and 5 = Completely Agree). Items 5, 6, 12, 17, 19, 20, 24, and 25 are reverse scored. Maximum score that can be obtained from the scale is 125. Higher scores from the subdomains or the entire scale are indicative of the fact that the patients' level of adaptation to the disease is also high. The Cronbach's Alpha value of the scale is 0.88 for the entire scale.
one weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Çanakkale Onsekiz Mart University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEVDA ATEŞ, Associate Professor, Çanakkale Onsekiz Mart University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COMU-SBF-SA-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Because patient data should not be shared during the ethics committee approval process.

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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