Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 4:08 PM
Study NCT ID:
NCT02999061
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2016-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition
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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-23', 'studyFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of dental caries.', 'timeFrame': '12 month', 'description': 'measured by counting the number of participants affected by dental caries/total number of study sample X100 , measurement unit is a percentage (%)'}], 'secondaryOutcomes': [{'measure': 'Assessment of oral hygiene .', 'timeFrame': '12 month', 'description': "using a Questionnaire (binary' yes or no questions'):-\n\n* record child brushing habits(once or twice)\n* consumption of fluoridated water (yes/no).\n* visits to dentists (yes/no)\n* Also using a dental mirror and a probe to detect presence of plaque (plaque index) and presence of caries (dmf score)."}, {'measure': 'Assessment of dietary habits', 'timeFrame': '12 month', 'description': 'questionnaire (binary "yes/no questions")about the past and current feeding habits:-\n\n* initial feeding of the child (breast or bottle answered yes/no)\n* length of the breast feeding ( normal \'0-2 years" or prolonged "\\>2years")\n* usage of bottle after weaning (yes/no). number of meals per day (one,two or three, answered in yes/no manner)\n* number of snacks per day (one,two or three in yes/no answers).\n* Also using a dental mirror and a probe to detect caries presence (dmf score), higher scores indicates faulty dietary habits.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pre-term children'], 'conditions': ['PreTerm Birth']}, 'referencesModule': {'references': [{'pmid': '18802992', 'type': 'BACKGROUND', 'citation': 'Brogardh-Roth S, Stjernqvist K, Matsson L. Dental behavioural management problems and dental caries prevalence in 3- to 6-year-old Swedish children born preterm. Int J Paediatr Dent. 2008 Sep;18(5):341-7. doi: 10.1111/j.1365-263x.2007.00884.x.'}, {'pmid': '20877971', 'type': 'BACKGROUND', 'citation': 'Cruvinel VR, Gravina DB, Azevedo TD, Bezerra AC, Toledo OA. Prevalence of dental caries and caries-related risk factors in premature and term children. Braz Oral Res. 2010 Jul-Sep;24(3):329-35. doi: 10.1590/s1806-83242010000300012.'}, {'pmid': '15242381', 'type': 'BACKGROUND', 'citation': 'Davenport ES, Litenas C, Barbayiannis P, Williams CE. The effects of diet, breast-feeding and weaning on caries risk for pre-term and low birth weight children. Int J Paediatr Dent. 2004 Jul;14(4):251-9. doi: 10.1111/j.1365-263X.2004.00557.x.'}, {'pmid': '19732193', 'type': 'BACKGROUND', 'citation': 'Seow WK, Lam JH, Tsang AK, Holcombe T, Bird PS. Oral Streptococcus species in pre-term and full-term children - a longitudinal study. Int J Paediatr Dent. 2009 Nov;19(6):406-11. doi: 10.1111/j.1365-263X.2009.01003.x. Epub 2009 Sep 1.'}, {'pmid': '9048413', 'type': 'BACKGROUND', 'citation': 'Lai PY, Seow WK, Tudehope DI, Rogers Y. Enamel hypoplasia and dental caries in very-low birthweight children: a case-controlled, longitudinal study. Pediatr Dent. 1997 Jan-Feb;19(1):42-9.'}, {'pmid': '21911951', 'type': 'BACKGROUND', 'citation': 'Rajshekar SA, Laxminarayan N. Comparison of primary dentition caries experience in pre-term low birth-weight and full-term normal birth-weight children aged one to six years. J Indian Soc Pedod Prev Dent. 2011 Apr-Jun;29(2):128-34. doi: 10.4103/0970-4388.84685.'}, {'pmid': '17822485', 'type': 'BACKGROUND', 'citation': 'Saraiva MC, Bettiol H, Barbieri MA, Silva AA. Are intrauterine growth restriction and preterm birth associated with dental caries? Community Dent Oral Epidemiol. 2007 Oct;35(5):364-76. doi: 10.1111/j.1600-0528.2006.00345.x.'}, {'pmid': '24731399', 'type': 'BACKGROUND', 'citation': 'Tanaka K, Miyake Y. Low birth weight, preterm birth or small-for-gestational-age are not associated with dental caries in young Japanese children. BMC Oral Health. 2014 Apr 14;14:38. doi: 10.1186/1472-6831-14-38.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.', 'detailedDescription': 'The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.\n\nPICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University Children\'s Hospital "Abo El-Rish" at El-Monira, Cairo, Egypt.\n\nOutcome (O) =prevalence of dental caries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'population is limited to preterm birth children aged 2-5 years with primary teeth only , both genders are included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 2-5 years old.\n* Presence of primary teeth only.\n* Children born preterm at gestational age of 6,7 and 8 month.\n\nExclusion Criteria:\n\n* Children with disability or mental disorders.\n* Children with immune compromising conditions.\n* Hospitalized and chronically ill children.'}, 'identificationModule': {'nctId': 'NCT02999061', 'briefTitle': 'Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across Sectional Study', 'orgStudyIdInfo': {'id': 'CEBC-CU-2016-12-169'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Cairo University Children\'s Hospital "Abo El-Rish" at El-Monira'}], 'overallOfficials': [{'name': 'Eman S Elmasry, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Samah M Awad, Ass.Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ohoud Tawfig ZainElabdeen', 'investigatorAffiliation': 'Cairo University'}}}}