Age ≥ 18 Years OldNCT07462208
Oral Health Intervention in Hemodialysis Patients
An observational study of Age ≥ 18 Years Old and Receiving HD Treatment at Least 6 Months, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age ≥ 18 Years Old, Receiving HD Treatment at Least 6 Months, Having no Hearing, Visual, or Speech Impairment
- What is being tested?
- Oral health education
- Type of treatment
- Pill or oral medicine
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2024to 3 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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,
Who cannot join
- Patients who refused to participate in the study,
- did not meet the inclusion criteria,
- did not consent to an oral examination,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Nursing, Faculty of Health Sciences, Canakkale Onsekiz Mart University
Çanakkale, 17100
About this study
Official title: 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.
Read the 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.
- Conditions
- Age ≥ 18 Years Old, Receiving HD Treatment at Least 6 Months, Having no Hearing, Visual, or Speech Impairment, Performing Self-oral Care
- Being tested
- Oral health education
- Keywords
- hemodialysis, oral health, oral care, adherence, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral health educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Oral health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start3 Jun 2024
- Primary completion3 Jul 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age ≥ 18 Years OldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sevda Ateş, Çanakkale Onsekiz Mart University
- Investigators
- SEVDA ATEŞ, Associate Professor, Principal investigator, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462208
- Sponsor's protocol ID
- COMU-SBF-SA-02
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because patient data should not be shared during the ethics committee approval process.
Publications
Ates S, Cetinkayali C. The effect of oral care education and reminder cards on patients receiving hemodialysis treatment: a quasi-experimental study. BMC Oral Health. 2026 Jul 15. doi: 10.1186/s12903-026-09310-6. Online ahead of print.
PubMed 42458382
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Care Education and Reminder Cards on Patients Receiving Hemodialysis Treatment: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07462208
- Acronym / sponsor ID
- COMU-SBF-SA-02
- Conditions
- Age ≥ 18 Years Old, Receiving HD Treatment at Least 6 Months, Having no Hearing, Visual, or Speech Impairment, Performing Self-oral Care
- Keywords
- hemodialysis, oral health, oral care, adherence, nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: Oral health educationExperimental: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (3 listed)
- Patients who refused to participate in the study,
- did not meet the inclusion criteria,
- did not consent to an oral examination,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral health educationAfter 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. | Other | experimental group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 42458382Ates S, Cetinkayali C. The effect of oral care education and reminder cards on patients receiving hemodialysis treatment: a quasi-experimental study. BMC Oral Health. 2026 Jul 15. doi: 10.1186/s12903-026-09310-6. Online ahead of print.
- Individual participant dataSharing planned: No. Because patient data should not be shared during the ethics committee approval process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEVDA ATEŞ, Associate Professor principal investigator
Çanakkale Onsekiz Mart University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age ≥ 18 Years Old and Receiving HD Treatment at Least 6 Months, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation to Chronic Illness Scale (time frame: one weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07462208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.