NCT06578832

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 167 (actual)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-10
• Primary completion: 2023-09-06
• Completion: 2024-01-18
• First posted: 2024-08-29
• Last updated: 2024-08-29

Locations

1 site across 1 country: Turkey (Türkiye)