Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT04344366
Status:
UNKNOWN
Last Update Posted:
2020-07-15
First Post:
2020-02-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Early Childhood Caries, Low Birth Weight and Nutritional Risk Factors: (Cohort Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-04-12', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early childhood caries', 'timeFrame': '1 year', 'description': 'Dental examination'}], 'secondaryOutcomes': [{'measure': 'Nutritional risk factors', 'timeFrame': '1 year', 'description': 'questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECC', 'premature birth'], 'conditions': ['ECC', 'LBW Children']}, 'referencesModule': {'references': [{'pmid': '31087372', 'type': 'BACKGROUND', 'citation': 'da Silva Castro CR, de Sousa Cabral MBB, Mota ELA, Cangussu MCT, Vianna MIP. Analysis of the influence of low birth weight on the time of eruption of dental caries in children in early childhood. J Public Health Dent. 2019 Dec;79(4):292-297. doi: 10.1111/jphd.12322. Epub 2019 May 13.'}, {'pmid': '24460034', 'type': 'BACKGROUND', 'citation': 'Masumo R, Birungi N, Bardsen A, Fadnes LT, Astrom AN. Impact of low birthweight on early childhood caries in 6-36 months old infants in Uganda: A cross-sectional study. Acta Odontol Scand. 2014 May;72(4):312-20. doi: 10.3109/00016357.2014.880189. Epub 2014 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the ECC experience in children aged from 12 to 36 month with low birth weight children in comparison to normal birth weight.', 'detailedDescription': 'Dental caries is on the top list of most widespread chronic diseases in addition to be a major public health issue. Dental caries is the single most common chronic childhood disease; it is 5 times more common than asthma, 7 times more common than hay fever and 14 times more common than chronic bronchitis. Deciduous tooth decay was ranked as the 12th most prevalent condition, affecting 560 million children in the 2015 Global Burden of Disease Study.\n\nLow birth weight and premature birth are highly related to infant mortality, perinatal infections and the poor growth and development of children. Some risk groups have been identified, and attention should be focused on them so that preventive and health promotion measures are taken in an attempt to reverse this situation. One of these risk groups is composed of children born prematurely. Prematurity may be a predisposing factor for the development of caries.\n\nThere is a strong relationship between birth weight and infant mortality and morbidity and chronic diseases later in life. Many studies discussed the association between birth weight and dental caries however the results were conflicting. Knowledge of the association between low birth weight and the risk factors of ECC and the associated nutritional risk factors will improve the preventive and health promotion measures for this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy, children aged from 12 to 36 month.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children.\n* Children aged from 12 to 36 month.\n\nExclusion Criteria:\n\n* Refusal of participation from the parents.\n* Medically compromised children\n* Major illness\n* Child with special needs\n* Any systemic disease that may affect caries experience.\n* Any congenital deformity that may affect caries experience.'}, 'identificationModule': {'nctId': 'NCT04344366', 'briefTitle': 'Association Between Early Childhood Caries, Low Birth Weight and Nutritional Risk Factors: (Cohort Study)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Association Between Early Childhood Caries, Low Birth Weight and Nutritional Risk Factors: (Cohort Study)', 'orgStudyIdInfo': {'id': 'ECC in LBW children'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A', 'description': 'children with low birth weight'}, {'label': 'group B', 'description': 'children with normal birth weight'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'dina morad', 'role': 'CONTACT', 'email': 'dina_farrag@dentistry.cu.edu.eg', 'phone': '01150316543'}], 'overallOfficials': [{'name': 'Ola Omar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Pediatric Dentistry and Dental Public Health'}, {'name': 'Marwa Ali', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of Pediatric Dentistry and Dental Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'dina farrag morad', 'investigatorAffiliation': 'Cairo University'}}}}