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Assessment of The Oral Health Status of Children With Chronic Kidney Disease

Completed
Conditions
Chronic Kidney Diseases
Caries,Dental
Quality of Life
Saliva Altered
Periodontitis
Interventions
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
Registration Number
NCT06578832
Lead Sponsor
Marmara University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
167
Inclusion Criteria
  • Not having any systemic disease.
  • Not being on any regular medication.
Exclusion Criteria
  • Having any systemic disease.
  • Being on any regular medication.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Children with stage 1-3 chronic kidney diseasebiochemical methodsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 1-3 chronic kidney disease
Children with chronic kidney diseaseQuality 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 groupphysical and chemical methodsHealthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications.
Healthy patient groupQuality 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 treatmentbiochemical testsIt 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 diseaseOral Health HabitsIt is a group of patients between the ages of 4 and 17 who have recently been diagnosed with jchronic kidney disease
Children with chronic kidney disease receiving dialysis treatmentphysical and chemical methodsIt 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 receiving dialysis treatmentbiochemical methodsIt 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 diseasephysical and chemical methodsIt is a group of patients between the ages of 4 and 17 who have recently been diagnosed with jchronic kidney disease
Children with chronic kidney diseasebiochemical methodsIt is a group of patients between the ages of 4 and 17 who have recently been diagnosed with jchronic kidney disease
Children with chronic kidney diseasebiochemical testsIt is a group of patients between the ages of 4 and 17 who have recently been diagnosed with jchronic kidney disease
Children with chronic kidney diseaseOral FindingsIt is a group of patients between the ages of 4 and 17 who have recently been diagnosed with jchronic kidney disease
Healthy patient groupbiochemical methodsHealthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications.
Healthy patient groupbiochemical testsHealthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications.
Healthy patient groupOral Health HabitsHealthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications.
Healthy patient groupOral FindingsHealthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications.
Children with chronic kidney disease receiving dialysis treatmentOral FindingsIt 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 transplantOral FindingsIt 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 chronic kidney disease who have undergone a kidney transplantQuality 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 chronic kidney disease receiving dialysis treatmentOral Health HabitsIt 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 receiving dialysis treatmentQuality 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 stage 1-3 chronic kidney diseasebiochemical testsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 1-3 chronic kidney disease
Children with chronic kidney disease who have undergone a kidney transplantOral Health HabitsIt 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 diseaseOral Health HabitsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 1-3 chronic kidney disease
Children with stage 1-3 chronic kidney diseaseQuality 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 diseasephysical and chemical methodsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease
Children with stage 4-5 chronic kidney diseaseOral Health HabitsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease
Children with stage 1-3 chronic kidney diseasephysical and chemical methodsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 1-3 chronic kidney disease
Children with stage 1-3 chronic kidney diseaseOral FindingsIt 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 diseasebiochemical testsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease
Children with stage 4-5 chronic kidney diseasebiochemical methodsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease
Children with stage 4-5 chronic kidney diseaseOral FindingsIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease
Children with stage 4-5 chronic kidney diseaseQuality of Life AssessmentIt is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease
Primary Outcome Measures
NameTimeMethod
Quality of Life (QoL)baseline

Quality of life scores on the KINDLR scale for both children with CKD and their parents

Oral Health Statusbaseline

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 Analysisbaseline

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.

Secondary Outcome Measures
NameTimeMethod
Correlation Between Salivary and Serum Calcium and Phosphorus Levels:baseline

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.

Correlation Between Oral Health Indices and Salivary Biomarkersbaseline

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.

Correlation Between Salivary Urea and Serum Urea Levelsbaseline

Correlation between salivary urea levels and serum urea levels. Pearson or Spearman correlation coefficient. Biochemical analysis for salivary and serum urea levels.

Trial Locations

Locations (1)

Marmara University Faculty of Dentistry

🇹🇷

Istanbul, Maltepe, Turkey

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