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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Chronic Kidney Diseases; Periodontitis; Caries,Dental; Saliva Altered
• Intervention / 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 Assessment

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 Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey
      • Marmara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Being followed up for a diagnosis of chronic kidney disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: physical and chemical methods; Salivary flow rate, pH, buffering capacity; Diagnostic test: biochemical methods; Total oxidant and antioxidant capacities; Diagnostic test: biochemical tests; urea, calcium, potassium, phosphorus; Diagnostic test: Oral Health Habits; Tooth brushing frequency Dental floss usage Annual dentist visits; Diagnostic test: Oral 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 test: Quality of Life Assessment; KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.
Healthy patient group; Healthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications.	Diagnostic test: physical and chemical methods; Salivary flow rate, pH, buffering capacity; Diagnostic test: biochemical methods; Total oxidant and antioxidant capacities; Diagnostic test: biochemical tests; urea, calcium, potassium, phosphorus; Diagnostic test: Oral Health Habits; Tooth brushing frequency Dental floss usage Annual dentist visits; Diagnostic test: Oral 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 test: Quality of Life Assessment; KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.
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.	Diagnostic test: physical and chemical methods; Salivary flow rate, pH, buffering capacity; Diagnostic test: biochemical methods; Total oxidant and antioxidant capacities; Diagnostic test: biochemical tests; urea, calcium, potassium, phosphorus; Diagnostic test: Oral Health Habits; Tooth brushing frequency Dental floss usage Annual dentist visits; Diagnostic test: Oral 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 test: Quality of Life Assessment; KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.
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.	Diagnostic test: Oral Health Habits; Tooth brushing frequency Dental floss usage Annual dentist visits; Diagnostic test: Oral 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 test: Quality of Life Assessment; KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.
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	Diagnostic test: physical and chemical methods; Salivary flow rate, pH, buffering capacity; Diagnostic test: biochemical methods; Total oxidant and antioxidant capacities; Diagnostic test: biochemical tests; urea, calcium, potassium, phosphorus; Diagnostic test: Oral Health Habits; Tooth brushing frequency Dental floss usage Annual dentist visits; Diagnostic test: Oral 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 test: Quality of Life Assessment; KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.
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	Diagnostic test: physical and chemical methods; Salivary flow rate, pH, buffering capacity; Diagnostic test: biochemical methods; Total oxidant and antioxidant capacities; Diagnostic test: biochemical tests; urea, calcium, potassium, phosphorus; Diagnostic test: Oral Health Habits; Tooth brushing frequency Dental floss usage Annual dentist visits; Diagnostic test: Oral 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 test: Quality of Life Assessment; KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	baseline

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; Chronic kidney disease; oral health; salivary
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Demineralization; Tooth Diseases; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Periodontitis; Dental Caries
• Other Study ID Numbers: 09.2022.961

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No