Assessment of The Oral Health Status of Children With Chronic Kidney Disease
1 other identifier
observational
167
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
1 active site
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
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2024
CompletedFirst Submitted
Initial submission to the registry
August 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedAugust 29, 2024
August 1, 2024
1.1 years
August 25, 2024
August 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
baseline
Quality of Life (QoL)
Quality of life scores on the KINDLR scale for both children with CKD and their parents
baseline
Secondary Outcomes (3)
Correlation Between Oral Health Indices and Salivary Biomarkers
baseline
Correlation Between Salivary Urea and Serum Urea Levels
baseline
Correlation Between Salivary and Serum Calcium and Phosphorus Levels:
baseline
Study Arms (6)
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
Healthy patient group
Healthy 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
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.
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.
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
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
Interventions
Salivary flow rate, pH, buffering capacity
Total oxidant and antioxidant capacities
urea, calcium, potassium, phosphorus
Tooth brushing frequency Dental floss usage Annual dentist visits
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.
KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.
Eligibility Criteria
Being followed up for a diagnosis of chronic kidney disease
You may qualify if:
- Not having any systemic disease.
- Not being on any regular medication.
You may not qualify if:
- Having any systemic disease.
- Being on any regular medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University Faculty of Dentistry
Istanbul, Maltepe, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 40105933DERIVED
Biospecimen
Saliva
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harika Alpay, Prof
Marmara University Faculty of Medicine
- STUDY CHAIR
İbrahim Gökçe, Prof
Marmara University Faculty of Medicine
- STUDY CHAIR
Nurdan Yıldız, Prof
Marmara University Faculty of Medicine
- STUDY CHAIR
Nihal Şehkar Oktay, Assoc. Prof
Marmara University Faculty of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2024
First Posted
August 29, 2024
Study Start
August 10, 2022
Primary Completion
September 6, 2023
Study Completion
January 18, 2024
Last Updated
August 29, 2024
Record last verified: 2024-08