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

• 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.

Study Timeline

• Study Start: 2022-08-10
• Primary Completion: 2023-09-06
• Study Completion: 2024-01-18
• Status Verified: 2024-08
• Study First Submitted: 2024-08-25
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29

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

Primary Outcome Measures

Name	Time	Method
Oral Health Status	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.
Quality of Life (QoL)	baseline	Quality of life scores on the KINDLR scale for both children with CKD and their parents
Salivary Analysis	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.

Secondary Outcome Measures

Name	Time	Method
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 Biomarkers	baseline	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 Levels	baseline	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