Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-27 @ 7:41 AM
Study NCT ID:
NCT06578832
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2024-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of The Oral Health Status of Children With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2024-08-25', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Health Status', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': 'Salivary Analysis', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': 'baseline', 'description': 'Quality of life scores on the KINDLR scale for both children with CKD and their parents'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Oral Health Indices and Salivary Biomarkers', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': 'Correlation Between Salivary Urea and Serum Urea Levels', 'timeFrame': 'baseline', 'description': 'Correlation between salivary urea levels and serum urea levels. Pearson or Spearman correlation coefficient. Biochemical analysis for salivary and serum urea levels.'}, {'measure': 'Correlation Between Salivary and Serum Calcium and Phosphorus Levels:', 'timeFrame': 'baseline', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'oral health', 'salivary', 'quality of life'], 'conditions': ['Chronic Kidney Diseases', 'Caries,Dental', 'Quality of Life', 'Saliva Altered', 'Periodontitis']}, 'referencesModule': {'references': [{'pmid': '40105933', 'type': 'DERIVED', 'citation': 'Kodaman Dokumacigil N, Sezer B, Oktay S, Alpay H, Kargul B. Dental caries, oral hygiene and salivary characteristics in children with chronic kidney disease: a case-control study. Pediatr Nephrol. 2025 Aug;40(8):2627-2637. doi: 10.1007/s00467-025-06730-4. Epub 2025 Mar 19.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Being followed up for a diagnosis of chronic kidney disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not having any systemic disease.\n* Not being on any regular medication.\n\nExclusion Criteria:\n\n* Having any systemic disease.\n* Being on any regular medication.'}, 'identificationModule': {'nctId': 'NCT06578832', 'briefTitle': 'Assessment of The Oral Health Status of Children With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Assessment of The Oral Health Status of Children With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '09.2022.961'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with chronic kidney disease', 'description': 'It is a group of patients between the ages of 4 and 17 who have recently been diagnosed with jchronic kidney disease', 'interventionNames': ['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']}, {'label': 'Healthy patient group', 'description': 'Healthy children aged between 4 and 17 years, with no systemic diseases and not taking any regular medications.', 'interventionNames': ['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']}, {'label': 'Children with chronic kidney disease receiving dialysis treatment', 'description': '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.', 'interventionNames': ['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']}, {'label': 'Children with chronic kidney disease who have undergone a kidney transplant', 'description': '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.', 'interventionNames': ['Diagnostic Test: Oral Health Habits', 'Diagnostic Test: Oral Findings', 'Diagnostic Test: Quality of Life Assessment']}, {'label': 'Children with stage 1-3 chronic kidney disease', 'description': 'It is a group of patients aged between 4 and 17 who have been diagnosed with stage 1-3 chronic kidney disease', 'interventionNames': ['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']}, {'label': 'Children with stage 4-5 chronic kidney disease', 'description': 'It is a group of patients aged between 4 and 17 who have been diagnosed with stage 4-5 chronic kidney disease', 'interventionNames': ['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']}], 'interventions': [{'name': 'physical and chemical methods', 'type': 'DIAGNOSTIC_TEST', 'description': 'Salivary flow rate, pH, buffering capacity', 'armGroupLabels': ['Children with chronic kidney disease', 'Children with chronic kidney disease receiving dialysis treatment', 'Children with stage 1-3 chronic kidney disease', 'Children with stage 4-5 chronic kidney disease', 'Healthy patient group']}, {'name': 'biochemical methods', 'type': 'DIAGNOSTIC_TEST', 'description': 'Total oxidant and antioxidant capacities', 'armGroupLabels': ['Children with chronic kidney disease', 'Children with chronic kidney disease receiving dialysis treatment', 'Children with stage 1-3 chronic kidney disease', 'Children with stage 4-5 chronic kidney disease', 'Healthy patient group']}, {'name': 'biochemical tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'urea, calcium, potassium, phosphorus', 'armGroupLabels': ['Children with chronic kidney disease', 'Children with chronic kidney disease receiving dialysis treatment', 'Children with stage 1-3 chronic kidney disease', 'Children with stage 4-5 chronic kidney disease', 'Healthy patient group']}, {'name': 'Oral Health Habits', 'type': 'DIAGNOSTIC_TEST', 'description': 'Tooth brushing frequency Dental floss usage Annual dentist visits', 'armGroupLabels': ['Children with chronic kidney disease', 'Children with chronic kidney disease receiving dialysis treatment', 'Children with chronic kidney disease who have undergone a kidney transplant', 'Children with stage 1-3 chronic kidney disease', 'Children with stage 4-5 chronic kidney disease', 'Healthy patient group']}, {'name': 'Oral Findings', 'type': 'DIAGNOSTIC_TEST', 'description': 'DMFT/dft Index: Measures decayed, missing, and filled teeth. ICDAS II: International Caries Detection and Assessment System, used for detecting and assessing dental caries.\n\nDDE Index: Developmental Defects of Enamel index. BAKH Index: Basic Anatomic Keratinization Hierarchy, typically used in specific studies.\n\nDI (Debris Index): Assesses oral hygiene based on the amount of debris on the teeth.\n\nCI (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.\n\nMGI (Modified Gingival Index): Assesses the severity of gingivitis based on inflammation.', 'armGroupLabels': ['Children with chronic kidney disease', 'Children with chronic kidney disease receiving dialysis treatment', 'Children with chronic kidney disease who have undergone a kidney transplant', 'Children with stage 1-3 chronic kidney disease', 'Children with stage 4-5 chronic kidney disease', 'Healthy patient group']}, {'name': 'Quality of Life Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': "KINDLR Scale: Used to assess disease-related quality of life from both the child's and the parent's perspectives.", 'armGroupLabels': ['Children with chronic kidney disease', 'Children with chronic kidney disease receiving dialysis treatment', 'Children with chronic kidney disease who have undergone a kidney transplant', 'Children with stage 1-3 chronic kidney disease', 'Children with stage 4-5 chronic kidney disease', 'Healthy patient group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Maltepe', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Faculty of Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'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', 'affiliation': 'Marmara University Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}