Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT07138456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in Rural Region, Dendera Center in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009050', 'term': 'Fluorosis, Dental'}], 'ancestors': [{'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 231}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-21', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically evident dental fluorosis in permanent incisors (prevalence)', 'timeFrame': 'Baseline (during the initial clinical examination of the child)', 'description': 'Clinical examination (using a probe and mouth mirror in bright daily life, using ICMR index which have the following scores 0: no fluorosis /1: mild fluorosis \\_ 2: moderate fluorosis / 3: severe fluorosis)'}], 'secondaryOutcomes': [{'measure': 'Clinically evident dental fluorosis in all permanent teeth present other than permanent incisors (prevalence)', 'timeFrame': 'Baseline (during the initial clinical examination of the child)', 'description': 'Clinical examination (using a probe and mouth mirror in bright daily life, using ICMR index which have the following scores 0: no fluorosis /1: mild fluorosis \\_ 2: moderate fluorosis / 3: severe fluorosis)'}, {'measure': 'Risk factors of dental fluorosis', 'timeFrame': 'baseline (upon enrollment, after parents complete the questionnaire)', 'description': "Multiple choice questions (questionnaire answered by the children's parents with multiple choice questions)."}, {'measure': 'Severity of dental fluorosis', 'timeFrame': 'Baseline (during the initial clinical examination of the child)', 'description': 'Scoring (0-3) according to Indian Council of Medical Research (ICMR) index which have the following scores 0: no fluorosis /1: mild fluorosis \\_ 2: moderate fluorosis / 3: severe fluorosis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prevalence, clinical severity and risk factors of dental fluorosis in a rural area in Egypt'], 'conditions': ['Dental Fluorosis']}, 'descriptionModule': {'briefSummary': 'The goal of our observational study is evaluation of the clinical severity of dental fluorosis and associated risk factors among a group of children (8-12 years old) in a rural region, Dendera center, Egypt.\n\nThe main question it aims to answer is:\n\nWhat is the clinical severity of dental fluorosis and associated risk factors among a group of children (8-12 years old) in a rural region, Dendera center, Egypt?', 'detailedDescription': 'Fluoride has a dual impact, it can be beneficial for dental health when consumed at optimal levels, but excessive intake can lead to a condition known as dental fluorosis (DF).\n\nDental fluorosis, which is particularly common among children and young individuals, is a developmental enamel defect caused by excessive fluoride exposure during the critical stages of tooth formation. This condition affects both the appearance and structure of the enamel.\n\nThe severity of dental fluorosis depends on various factors, including fluoride concentration in drinking water, daily intake, duration of exposure, and climatic conditions.\n\nEpidemiological studies indicate that fluorosis can affect individuals across different age groups, with cases ranging from mild dental fluorosis to severe skeletal fluorosis. Children are particularly vulnerable to its harmful effects, which are often irreversible.\n\nIn rural areas, groundwater serves as the primary source of drinking water due to limited access to treated water supplies.\n\nThis dependence on groundwater increases the risk of prolonged fluoride exposure, particularly among children, whose developing teeth are more susceptible to fluorosis.\n\nWhile several studies have documented the prevalence of dental fluorosis globally, there is a lack of data on its prevalence in rural areas of Upper Egypt, where groundwater is a key water source.\n\nThis knowledge gap highlights the need for localized research to assess the extent of the issue and develop targeted interventions.\n\nTherefore, a cross-sectional study will be conducted to determine the prevalence and severity of dental fluorosis and identify associated risk factors among children in a rural area of the Dendera district, Qena governorate, Upper Egypt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thy should be children with age range from 8 to 12 years, who have lived in the area of study since birth.\n\nthe teeth to be examined should be clean and not covered with fillings or braces.\n\nthe parents and children should accept to participate in the study and the parents should sign a consent according to ethical consideration.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Children age range from 8 to 12 years.\n* Children have lived in the area of the study since birth.\n* Teeth to be examined should not be covered with fillings or braces.\n\nExclusion criteria:\n\n* Parents or children who refuse to participate in the study.\n* Ethical consideration.'}, 'identificationModule': {'nctId': 'NCT07138456', 'briefTitle': 'Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in Rural Region, Dendera Center in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in a Rural Region, Dendera Center in Egypt: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'prevalence and severity of DF'}}, 'contactsLocationsModule': {'locations': [{'zip': '83511', 'city': 'Cairo', 'state': 'Qena Governorate', 'country': 'Egypt', 'facility': 'Dendera region'}], 'centralContacts': [{'name': 'Gihad M Abdelraheem, Master', 'role': 'CONTACT', 'email': 'gihad.mohamed@dentistry.cu.edu.eg', 'phone': 'Egypt: +201095472833'}, {'name': 'Ghadeer M Sayed, master', 'role': 'CONTACT', 'email': 'ghadeer.mohamed@dentistry.cu.edu.eg', 'phone': 'Egypt: +201023724105'}], 'overallOfficials': [{'name': 'sarah A Mahmoud, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gihad Mohamed Abdelraheem Abdelmajeed', 'investigatorFullName': 'Gihad Mohamed Abdelraheem Abdelmajeed', 'investigatorAffiliation': 'Cairo University'}}}}