Clinical trial NCT06578832: Assessment of The Oral Health Status of Children With Chronic Kidney Disease
Official title: Assessment of The Oral Health Status of Children With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Caries,Dental
Quality of Life
Saliva Altered
Periodontitis
Keywords: Chronic kidney disease
oral health
salivary
quality of life
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 167
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Being followed up for a diagnosis of chronic kidney disease

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Oral Health Status
timeFrame: baseline
measure: Salivary Analysis
timeFrame: baseline
measure: Quality of Life (QoL)
timeFrame: baseline
Secondary outcomes:
measure: Correlation Between Oral Health Indices and Salivary Biomarkers
timeFrame: baseline
measure: Correlation Between Salivary Urea and Serum Urea Levels
timeFrame: baseline
measure: Correlation Between Salivary and Serum Calcium and Phosphorus Levels:
timeFrame: baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Dentistry
state: Maltepe
Study officials:
affiliation: Marmara University Faculty of Medicine
name: Harika Alpay, Prof
role: STUDY_CHAIR
affiliation: Marmara University Faculty of Medicine
name: İbrahim Gökçe, Prof
role: STUDY_CHAIR
affiliation: Marmara University Faculty of Medicine
name: Nurdan Yıldız, Prof
role: STUDY_CHAIR
affiliation: Marmara University Faculty of Medicine
name: Nihal Şehkar Oktay, Assoc. Prof
role: STUDY_CHAIR
References: