Chronic Kidney DiseasesNCT06578832
Assessment of The Oral Health Status of Children With Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Caries,Dental, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the oral health findings, salivary parameters and disease-related quality of life of children with different stages of Chronic Kidney Disease(CKD), those undergoing dialysis and transplantation, with healthy children, and to evaluate certain serum biomarkers in children with CKD. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Caries,Dental, Quality of Life
- What is being tested?
- physical and chemical methods, biochemical methods and biochemical tests
- Type of treatment
- Pill or oral medicine
- How many people
- 167 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2022to 18 Jan 2024
- How long will I take part?
- 6 Months
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Being followed up for a diagnosis of chronic kidney disease
Who may be able to join
- Not having any systemic disease.
- Not being on any regular medication.
Who cannot join
- Having any systemic disease.
- Being on any regular medication.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, Maltepe
About this study
The aim of this study is to compare the oral health findings, salivary parameters and disease-related quality of life of children with different stages of Chronic Kidney Disease(CKD), those undergoing dialysis and transplantation, with healthy children, and to evaluate certain serum biomarkers in children with CKD.
Read the detailed description
Chronic kidney disease (CKD) is a progressive and irreversible decline in the function of many nephrons and glomerular filtration rate due to kidney diseases. This decline leads to increased serum levels of urea and creatinine. Patients with CKD often exhibit various oral manifestations, such as an ammonia-like odor, gingival enlargement due to drug therapy, enamel hypoplasia, dental calculus, dry mouth, uremic stomatitis, and oral mucosal lesions. Interestingly, children with CKD tend to have a lower prevalence of dental caries, likely due to the high urea content in their saliva, which has antibacterial properties. CKD is also associated with salivary gland dysfunction and increased oxidative damage. Furthermore, CKD patients have reduced bone quality, making them more susceptible to fractures. A study on the quality of life (QoL) in children with CKD and their parents reported significantly lower physical and social QoL scores in children undergoing hemodialysis compared to healthy controls. This study aims to comparatively evaluate and analyze children diagnosed with different stages of chronic kidney disease (CKD) and healthy children without any systemic conditions, focusing on their age, gender, and oral health habits such as tooth brushing frequency, dental floss usage, and annual dentist visits. Disease-related information such as the stage of CKD, dialysis, and transplantation, as well as oral findings, will be examined using DMFT/dft, ICDAS II, DDE, BAKH, DI, CI, OHI-S, and MGI indices. The study will assess general disease-related quality of life from both the child's and the parent's perspectives using the KINDLR scale. Additionally, salivary samples collected from children with CKD and healthy children will be analyzed for salivary flow rate, pH, buffering capacity, total oxidant and antioxidant capacities, urea, calcium, potassium, and phosphorus levels. Serum urea, calcium, and phosphorus values will also be examined.
- Being tested
- physical and chemical methods, biochemical methods, biochemical tests, Oral Health Habits, Oral Findings
- Keywords
- Chronic kidney disease, oral health, salivary, quality of life
- Medical subject headings
- Renal Insufficiency, Chronic, Dental Caries, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical and chemical methodsDiagnostic test
Salivary flow rate, pH, buffering capacity
biochemical methodsDiagnostic test
Total oxidant and antioxidant capacities
biochemical testsDiagnostic test
urea, calcium, potassium, phosphorus
Oral Health HabitsDiagnostic test
Tooth brushing frequency Dental floss usage Annual dentist visits
Oral FindingsDiagnostic test
DMFT/dft Index: Measures decayed, missing, and filled teeth. ICDAS II: International Caries Detection and Assessment System, used for detecting and assessing dental caries.
DDE Index: Developmental Defects of Enamel index. BAKH Index: Basic Anatomic Keratinization Hierarchy, typically used in specific studies.
DI (Debris Index): Assesses oral hygiene based on the amount of debris on the teeth.
CI (Calculus Index): Measures the amount of calculus (tartar) on the teeth. OHI-S (Simplified Oral Hygiene Index): Assesses oral hygiene based on the presence of debris and calculus.
MGI (Modified Gingival Index): Assesses the severity of gingivitis based on inflammation.
Quality of Life AssessmentDiagnostic test
KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.
| Study group | Role | What they receive |
|---|---|---|
| Children with chronic kidney disease | It is a group of patients between the ages of 4 and 17 who have recently been diagnosed with jchronic kidney disease Receives: Diagnostic Test: physical and chemical methods; Diagnostic Test: biochemical methods; Diagnostic Test: biochemical tests; Diagnostic Test: Oral Health Habits; Diagnostic Test: Oral Findings; Diagnostic Test: Quality of Life Assessment | |
| Healthy patient group | Healthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications. Receives: Diagnostic Test: physical and chemical methods; Diagnostic Test: biochemical methods; Diagnostic Test: biochemical tests; Diagnostic Test: Oral Health Habits; Diagnostic Test: Oral Findings; Diagnostic Test: Quality of Life Assessment | |
| Children with chronic kidney disease receiving dialysis treatment | It is a group of patients aged between 4 and 17 who have recently been diagnosed with chronic kidney disease and are receiving dialysis treatment. Receives: Diagnostic Test: physical and chemical methods; Diagnostic Test: biochemical methods; Diagnostic Test: biochemical tests; Diagnostic Test: Oral Health Habits; Diagnostic Test: Oral Findings; Diagnostic Test: Quality of Life Assessment | |
| Children with chronic kidney disease who have undergone a kidney transplant | It is a group of patients aged between 4 and 17 who have recently been diagnosed with chronic kidney disease and have undergone a kidney transplant. Receives: Diagnostic Test: Oral Health Habits; Diagnostic Test: Oral Findings; Diagnostic Test: Quality of Life Assessment | |
| Children with stage 1-3 chronic kidney disease | It is a group of patients aged between 4 and 17 who have been diagnosed with stage 1-3 chronic kidney disease Receives: Diagnostic Test: physical and chemical methods; Diagnostic Test: biochemical methods; Diagnostic Test: biochemical tests; Diagnostic Test: Oral Health Habits; Diagnostic Test: Oral Findings; Diagnostic Test: Quality of Life Assessment | |
| Children with stage 4-5 chronic kidney disease | It is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease Receives: Diagnostic Test: physical and chemical methods; Diagnostic Test: biochemical methods; Diagnostic Test: biochemical tests; Diagnostic Test: Oral Health Habits; Diagnostic Test: Oral Findings; Diagnostic Test: Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Status
DMFT/dft indices, DI (Debris Index), CI (Calculus Index), and OHI-S (Simplified Oral Hygiene Index) scores,DDE Index (Developmental Defect of Enamel), MGI Index (Modified Gingival Index) and ICDAS-II. DMFT/dft index values, DI, CI, and OHI-S scores as numerical values. DDE, MGI Index and ICDAS-II are percentage of participants with these conditions. Prevalence of limited opacities, caries and gingival inflammation based on DDE, ICDAS II and MGI indices.
Measured: baseline
Salivary Analysis
Salivary urea, calcium (Ca), potassium (K), phosphorus (P), total oxidant status (TOS) levels, and salivary flow rate. Concentration of urea, Ca, K, P, TOS in mg/dL or equivalent, and salivary flow rate in mL/min.
Measured: baseline
Quality of Life (QoL)
Quality of life scores on the KINDLR scale for both children with CKD and their parents
Measured: baseline
Secondary outcomes (3)
Correlation Between Oral Health Indices and Salivary Biomarkers
Correlation between DMFT/dft index, DI, CI, OHI-S scores, and salivary levels of urea, calcium (Ca), potassium (K), phosphorus (P), total oxidant status (TOS), and total antioxidant status (TAS). Pearson or Spearman correlation coefficient. DMFT/dft index, DI, CI, OHI-S scores for oral health assessment; biochemical analysis for salivary biomarker levels.
Measured: baseline
Correlation Between Salivary Urea and Serum Urea Levels
Correlation between salivary urea levels and serum urea levels. Pearson or Spearman correlation coefficient. Biochemical analysis for salivary and serum urea levels.
Measured: baseline
Correlation Between Salivary and Serum Calcium and Phosphorus Levels:
Correlation between salivary calcium and phosphorus levels and serum calcium and phosphorus levels. Pearson or Spearman correlation coefficient. Biochemical analysis for salivary and serum calcium and phosphorus levels.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start10 Aug 2022
- Primary completion6 Sep 2023
- Study completion18 Jan 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 Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 167 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harika Alpay, Prof, Study chair, Marmara University Faculty of Medicineİbrahim Gökçe, Prof, Study chair, Marmara University Faculty of MedicineNurdan Yıldız, Prof, Study chair, Marmara University Faculty of MedicineNihal Şehkar Oktay, Assoc. Prof, Study chair, Marmara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578832
- Sponsor's protocol ID
- 09.2022.961
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kodaman Dokumacigil N, Sezer B, Oktay S, Alpay H, Kargul B. Dental caries, oral hygiene and salivary characteristics in children with chronic kidney disease: a case-control study. Pediatr Nephrol. 2025 Aug;40(8):2627-2637. doi: 10.1007/s00467-025-06730-4. Epub 2025 Mar 19.
PubMed 40105933
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of The Oral Health Status of Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06578832
- Acronym / sponsor ID
- 09.2022.961
- Keywords
- Chronic kidney disease, oral health, salivary, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 29 Aug 2024 (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.
The aim of this study is to compare the oral health findings, salivary parameters and disease-related quality of life of children with different stages of Chronic Kidney Disease(CKD), those undergoing dialysis and transplantation, with healthy children, and to evaluate certain serum biomarkers in children with CKD.
Detailed description
Chronic kidney disease (CKD) is a progressive and irreversible decline in the function of many nephrons and glomerular filtration rate due to kidney diseases. This decline leads to increased serum levels of urea and creatinine. Patients with CKD often exhibit various oral manifestations, such as an ammonia-like odor, gingival enlargement due to drug therapy, enamel hypoplasia, dental calculus, dry mouth, uremic stomatitis, and oral mucosal lesions. Interestingly, children with CKD tend to have a lower prevalence of dental caries, likely due to the high urea content in their saliva, which has antibacterial properties. CKD is also associated with salivary gland dysfunction and increased oxidative damage. Furthermore, CKD patients have reduced bone quality, making them more susceptible to fractures. A study on the quality of life (QoL) in children with CKD and their parents reported significantly lower physical and social QoL scores in children undergoing hemodialysis compared to healthy controls. This study aims to comparatively evaluate and analyze children diagnosed with different stages of chronic kidney disease (CKD) and healthy children without any systemic conditions, focusing on their age, gender, and oral health habits such as tooth brushing frequency, dental floss usage, and annual dentist visits. Disease-related information such as the stage of CKD, dialysis, and transplantation, as well as oral findings, will be examined using DMFT/dft, ICDAS II, DDE, BAKH, DI, CI, OHI-S, and MGI indices. The study will assess general disease-related quality of life from both the child's and the parent's perspectives using the KINDLR scale. Additionally, salivary samples collected from children with CKD and healthy children will be analyzed for salivary flow rate, pH, buffering capacity, total oxidant and antioxidant capacities, urea, calcium, potassium, and phosphorus levels. Serum urea, calcium, and phosphorus values will also be examined.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Children with chronic kidney disease | – | Diagnostic Test: physical and chemical methods, Diagnostic Test: biochemical methods, Diagnostic Test: biochemical tests, Diagnostic Test: Oral Health Habits, Diagnostic Test: Oral Findings, Diagnostic Test: Quality of Life AssessmentIt is a group of patients between the ages of 4 and 17 who have recently been diagnosed with jchronic kidney disease |
| Healthy patient group | – | Diagnostic Test: physical and chemical methods, Diagnostic Test: biochemical methods, Diagnostic Test: biochemical tests, Diagnostic Test: Oral Health Habits, Diagnostic Test: Oral Findings, Diagnostic Test: Quality of Life AssessmentHealthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications. |
| Children with chronic kidney disease receiving dialysis treatment | – | Diagnostic Test: physical and chemical methods, Diagnostic Test: biochemical methods, Diagnostic Test: biochemical tests, Diagnostic Test: Oral Health Habits, Diagnostic Test: Oral Findings, Diagnostic Test: Quality of Life AssessmentIt is a group of patients aged between 4 and 17 who have recently been diagnosed with chronic kidney disease and are receiving dialysis treatment. |
| Children with chronic kidney disease who have undergone a kidney transplant | – | Diagnostic Test: Oral Health Habits, Diagnostic Test: Oral Findings, Diagnostic Test: Quality of Life AssessmentIt is a group of patients aged between 4 and 17 who have recently been diagnosed with chronic kidney disease and have undergone a kidney transplant. |
| Children with stage 1-3 chronic kidney disease | – | Diagnostic Test: physical and chemical methods, Diagnostic Test: biochemical methods, Diagnostic Test: biochemical tests, Diagnostic Test: Oral Health Habits, Diagnostic Test: Oral Findings, Diagnostic Test: Quality of Life AssessmentIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 1-3 chronic kidney disease |
| Children with stage 4-5 chronic kidney disease | – | Diagnostic Test: physical and chemical methods, Diagnostic Test: biochemical methods, Diagnostic Test: biochemical tests, Diagnostic Test: Oral Health Habits, Diagnostic Test: Oral Findings, Diagnostic Test: Quality of Life AssessmentIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Being followed up for a diagnosis of chronic kidney disease
Key inclusion criteria (2 listed)
- Not having any systemic disease.
- Not being on any regular medication.
Key exclusion criteria (2 listed)
- Having any systemic disease.
- Being on any regular medication.
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 |
|---|---|---|
| physical and chemical methodsSalivary flow rate, pH, buffering capacity | Diagnostic test | Children with chronic kidney disease, Children with chronic kidney disease receiving dialysis treatment, Children with stage 1-3 chronic kidney disease, Children with stage 4-5 chronic kidney disease, Healthy patient group |
| biochemical methodsTotal oxidant and antioxidant capacities | Diagnostic test | Children with chronic kidney disease, Children with chronic kidney disease receiving dialysis treatment, Children with stage 1-3 chronic kidney disease, Children with stage 4-5 chronic kidney disease, Healthy patient group |
| biochemical testsurea, calcium, potassium, phosphorus | Diagnostic test | Children with chronic kidney disease, Children with chronic kidney disease receiving dialysis treatment, Children with stage 1-3 chronic kidney disease, Children with stage 4-5 chronic kidney disease, Healthy patient group |
| Oral Health HabitsTooth brushing frequency Dental floss usage Annual dentist visits | Diagnostic test | Children with chronic kidney disease, Children with chronic kidney disease receiving dialysis treatment, Children with chronic kidney disease who have undergone a kidney transplant, Children with stage 1-3 chronic kidney disease, Children with stage 4-5 chronic kidney disease, Healthy patient group |
| Oral FindingsDMFT/dft Index: Measures decayed, missing, and filled teeth. ICDAS II: International Caries Detection and Assessment System, used for detecting and assessing dental caries. DDE Index: Developmental Defects of Enamel index. BAKH Index: Basic Anatomic Keratinization Hierarchy, typically used in specific studies. DI (Debris Index): Assesses oral hygiene based on the amount of debris on the teeth. CI (Calculus Index): Measures the amount of calculus (tartar) on the teeth. OHI-S (Simplified Oral Hygiene Index): Assesses oral hygiene based on the presence of debris and calculus. MGI (Modified Gingival Index): Assesses the severity of gingivitis based on inflammation. | Diagnostic test | Children with chronic kidney disease, Children with chronic kidney disease receiving dialysis treatment, Children with chronic kidney disease who have undergone a kidney transplant, Children with stage 1-3 chronic kidney disease, Children with stage 4-5 chronic kidney disease, Healthy patient group |
| Quality of Life AssessmentKINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives. | Diagnostic test | Children with chronic kidney disease, Children with chronic kidney disease receiving dialysis treatment, Children with chronic kidney disease who have undergone a kidney transplant, Children with stage 1-3 chronic kidney disease, Children with stage 4-5 chronic kidney disease, Healthy patient group |
Primary outcome
Oral Health Status
Time frame: baseline
DMFT/dft indices, DI (Debris Index), CI (Calculus Index), and OHI-S (Simplified Oral Hygiene Index) scores,DDE Index (Developmental Defect of Enamel), MGI Index (Modified Gingival Index) and ICDAS-II. DMFT/dft index values, DI, CI, and OHI-S scores as numerical values. DDE, MGI Index and ICDAS-II are percentage of participants with these conditions. Prevalence of limited opacities, caries and gingival inflammation based on DDE, ICDAS II and MGI indices.
Salivary Analysis
Time frame: baseline
Salivary urea, calcium (Ca), potassium (K), phosphorus (P), total oxidant status (TOS) levels, and salivary flow rate. Concentration of urea, Ca, K, P, TOS in mg/dL or equivalent, and salivary flow rate in mL/min.
Quality of Life (QoL)
Time frame: baseline
Quality of life scores on the KINDLR scale for both children with CKD and their parents
3 secondary outcomes
Correlation Between Oral Health Indices and Salivary Biomarkers
Time frame: baseline
Correlation Between Salivary Urea and Serum Urea Levels
Time frame: baseline
Correlation Between Salivary and Serum Calcium and Phosphorus Levels:
Time frame: baseline
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 29 Aug 2024.
- Derived from this study: PubMed 40105933Kodaman Dokumacigil N, Sezer B, Oktay S, Alpay H, Kargul B. Dental caries, oral hygiene and salivary characteristics in children with chronic kidney disease: a case-control study. Pediatr Nephrol. 2025 Aug;40(8):2627-2637. doi: 10.1007/s00467-025-06730-4. Epub 2025 Mar 19.
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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.
Harika Alpay, Prof study chair
Marmara University Faculty of Medicine
İbrahim Gökçe, Prof study chair
Marmara University Faculty of Medicine
Nurdan Yıldız, Prof study chair
Marmara University Faculty of Medicine
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 Chronic Kidney Diseases and Caries,Dental, run by Marmara 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 2 inclusion and 2 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 29 Aug 2024. 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?
Oral Health Status (time frame: baseline). The study lists 3 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 NCT06578832, 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 29 Aug 2024.