NCT07462208

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 5, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

hemodialysisoral healthoral careadherencenursing

Outcome Measures

Primary Outcomes (4)

  • Adaptation to Chronic Illness Scale

    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

  • Oral Assessment Guide

    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

    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

    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

Study Arms (1)

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

Interventions

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.

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing, Faculty of Health Sciences, Canakkale Onsekiz Mart University

Çanakkale, 17100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Health Education, Dental

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health DentistryEnvironment and Public Health

Study Officials

  • SEVDA ATEŞ, Associate Professor

    Çanakkale Onsekiz Mart University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 10, 2026

Study Start

June 3, 2024

Primary Completion

July 3, 2024

Study Completion

October 3, 2024

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations