Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-28 @ 9:24 PM
Study NCT ID:
NCT06439095
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2024-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interleukin-2 (IL-2), Interleukin-5 (IL-5) and Interleukin-17 (IL-17) Levels of Patients With Stainless Steel Crowns
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006863', 'term': 'Hydrogen-Ion Concentration'}], 'ancestors': [{'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'burcinavci@yyu.edu.tr', 'phone': '+90 5359558140', 'title': 'Dr. Burçin Avcı, Assistant Professor', 'organization': 'Van Yuzuncu Yil University Faculty of Dentistry'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The small sample size and short 7-day follow-up limit the generalizability and long-term interpretation of the results. The before-and-after design reduces variability but does not fully control for genetic, immune, or environmental factors. Larger randomized studies are needed to confirm these findings.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline until 7 days post-treatment', 'description': 'Adverse events were monitored through systematic clinical examination and parental interviews.', 'eventGroups': [{'id': 'EG000', 'title': 'Stainless Steel Crown Group', 'description': 'Participants in this group received stainless steel crowns on posterior teeth. Salivary samples were collected before treatment (pre-treatment) and 7 days after treatment. IL-2, IL-5, and IL-17 gene expression levels were measured using Real-Time PCR. Additionally, salivary pH and the concentration of nickel, chrome ions were analyzed using atomic absorption spectrophotometry.\n\nSalivary Collection: Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 3-9 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 3 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure.\n\nPh and ion level measurement of saliva: Salivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IL-2, IL-5, IL-17 Expression Level (Fold Change)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stainless Steel Crown Group', 'description': 'Patients received stainless steel crowns on posterior teeth. Salivary IL-2, IL-5, and IL-17 gene expression levels were measured before treatment and 7 days after.'}], 'classes': [{'title': 'Day 7 IL-2 Expression (Fold Change)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 IL-5 Expression (Fold Change)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 IL-17 Expression (Fold Change)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Sample collection at baseline (Day 0) and 7 days after treatment', 'description': 'Relative gene expression analysis was performed using quantitative PCR (qPCR) with appropriate primers. The results were reported as fold change relative to baseline values.', 'unitOfMeasure': 'Fold Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 12 enrolled participants, data from 10 participants were included in the final analysis due to complete sample availability.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stainless Steel Crown Group', 'description': 'Patients received stainless steel crowns, and salivary IL-2, IL-5, and IL-17 gene expression levels were measured at baseline and after 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from pediatric dental clinics and selected based on the need for stainless steel crown placement.', 'preAssignmentDetails': 'Twelve patients were enrolled according to the study protocol and all twelve commenced the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Stainless Steel Crown Group', 'description': 'Patients received stainless steel crowns, and salivary IL-2, IL-5, and IL-17 gene expression levels were measured at baseline and after 7 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Baseline IL-2, IL-5, and IL-17 Expression Status', 'classes': [{'title': 'Baseline IL-2 Expression (Relative Units)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.1', 'groupId': 'BG000'}]}]}, {'title': 'Baseline IL-5 Expression (Relative Units)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.15', 'groupId': 'BG000'}]}]}, {'title': 'Baseline IL-17 Expression (Relative Units)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Average baseline IL-2, IL-5, and IL-17 expression levels measured in saliva before SSC procedure.', 'unitOfMeasure': 'Relative Expression Units', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline data was collected from all 12 participants before 2 participants were withdrawn due to loss to follow-up.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-01', 'size': 109802, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-06-03T04:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva of patients using stainless steel crown'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2024-05-27', 'resultsFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-03', 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-2, IL-5, IL-17 Expression Level (Fold Change)', 'timeFrame': 'Sample collection at baseline (Day 0) and 7 days after treatment', 'description': 'Relative gene expression analysis was performed using quantitative PCR (qPCR) with appropriate primers. The results were reported as fold change relative to baseline values.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Saliva', 'Dental crown', 'Gene expression'], 'conditions': ['Saliva', 'Dental Crown', 'Nickel Sensitivity']}, 'descriptionModule': {'briefSummary': "The aim of this study is to investigate whether nickel hypersensitivity following stainless steel crown treatment in children aged 3-9 leads to an increase in IL-2, IL-5, and IL-17 levels by analyzing saliva samples. By doing so, the study seeks to prevent potential hypersensitivity reactions after stainless steel crown treatment.\n\nThe main question it aims to answer is:\n\nWhich interleukin level increases in the controls 1 week after stainless steel crowns are applied? Researchers will investigate whether there is a significant increase in interleukin levels in children's saliva before and after the procedure.\n\nParticipants will:\n\nThey will provide saliva samples before stainless steel crowns are applied They will visit the clinic after 1 week for check-ups and tests.", 'detailedDescription': 'Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 3-9 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 5 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure. Also ph value and ion levels of saliva will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients living in Van city', 'eligibilityCriteria': '\\*\\*Inclusion Criteria:\\*\\*\n\n* Patients with teeth requiring stainless steel crowns due to having caries on two or more surfaces.\n* Pediatric patients between 3-9 years old\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Patients having any dental materials, such as fillings, fissure sealants, root canal treatments, or space maintainers\n* Patients with known allergies to various foods and materials.\n* Patients with systemic diseases that affect the immune system.\n* Patients with a history of chemotherapy or radiotherapy.'}, 'identificationModule': {'nctId': 'NCT06439095', 'briefTitle': 'Interleukin-2 (IL-2), Interleukin-5 (IL-5) and Interleukin-17 (IL-17) Levels of Patients With Stainless Steel Crowns', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Evaluation of IL-2, IL-5 and IL-17 Expression Levels in Saliva of Patients Treated With Stainless Steel Crowns', 'orgStudyIdInfo': {'id': 'YYU-BAVCI-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stainless Steel Crown Group', 'description': 'Participants in this group received stainless steel crowns on posterior teeth. Salivary samples were collected before treatment (pre-treatment) and 7 days after treatment. IL-2, IL-5, and IL-17 gene expression levels were measured using Real-Time PCR. Additionally, salivary pH and the concentration of nickel, chrome ions were analyzed using atomic absorption spectrophotometry.', 'interventionNames': ['Genetic: Salivary Collection', 'Diagnostic Test: Ph and ion level measurement of saliva']}], 'interventions': [{'name': 'Salivary Collection', 'type': 'GENETIC', 'description': 'Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 3-9 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 3 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure.', 'armGroupLabels': ['Stainless Steel Crown Group']}, {'name': 'Ph and ion level measurement of saliva', 'type': 'DIAGNOSTIC_TEST', 'description': 'Salivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer.', 'armGroupLabels': ['Stainless Steel Crown Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65080', 'city': 'Van', 'state': 'Tuşba', 'country': 'Turkey (Türkiye)', 'facility': 'Yüzüncü Yil University', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'Burçin Avcı, DDS, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Burçin AVCI', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}