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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06578832
Enrollment
167
Registered
2024-08-29
Start date
2022-08-10
Completion date
2024-01-18
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Caries,Dental, Quality of Life, Saliva Altered, Periodontitis

Keywords

Chronic kidney disease, oral health, salivary, quality of life

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.

Interventions

Salivary flow rate, pH, buffering capacity

DIAGNOSTIC_TESTbiochemical methods

Total oxidant and antioxidant capacities

DIAGNOSTIC_TESTbiochemical tests

urea, calcium, potassium, phosphorus

DIAGNOSTIC_TESTOral Health Habits

Tooth brushing frequency Dental floss usage Annual dentist visits

DIAGNOSTIC_TESTOral Findings

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.

DIAGNOSTIC_TESTQuality of Life Assessment

KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Not having any systemic disease. * Not being on any regular medication.

Exclusion criteria

* Having any systemic disease. * Being on any regular medication.

Design outcomes

Primary

MeasureTime frameDescription
Oral Health StatusbaselineDMFT/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 AnalysisbaselineSalivary 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)baselineQuality of life scores on the KINDLR scale for both children with CKD and their parents

Secondary

MeasureTime frameDescription
Correlation Between Oral Health Indices and Salivary BiomarkersbaselineCorrelation 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 LevelsbaselineCorrelation between salivary urea levels and serum urea levels. Pearson or Spearman correlation coefficient. Biochemical analysis for salivary and serum urea levels.
Correlation Between Salivary and Serum Calcium and Phosphorus Levels:baselineCorrelation 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026